Geroscience is a research paradigm based in understanding the genetic, molecular and cellular mechanisms that make aging a major risk factor for and driver of common chronic conditions and diseases of older people. Geroscience research seeks to understand how aging affects the disease process and to use that knowledge to slow the rate of aging, reverse its effects, and delay or even cure age-related diseases.
The Translational Geroscience Network (TGN) is a collaboration of researchers looking at clinical interventions that target fundamental mechanisms of aging to delay, prevent or treat age-related diseases and disabilities as a group, instead of one at a time.
Network Clinical Trials
The Translational Geroscience Network (TGN) maintains this list of clinical trials in which the network is directly involved. This list, including most of its section headers, are dynamically updated with detail by clinicaltrials.gov to showcase the Network's progress, collaboration, and expansion. This list can be searched or exported as a spreadsheet.
| NCT # | Title | Brief Summary | Acronym | Status | Publications | Stored Specimens | Conditions | Interventions | Primary Outcome Measures | Secondary Outcome Measures | Other Outcome Measures | Sponsor | Collaborators | Gender | Age | Phases | Enrollment | Funder Type | Study Type | Study Designs | Other IDs | Start Date | Primary Completion Date | Completion Date | First Posted | Results First Posted | Last Update Posted | Locations | Study Documents | URL |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02848131 | Senescence in Chronic Kidney Disease | The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD). | ENROLLING_BY_INVITATION | PMID: 31542391 PMID: 35615688 | Chronic Kidney Disease | DRUG: Group 2: Dasatinib|DRUG: Group 2: Quercetin | Change in proportion of senescent cells (representing the total senescent cell burden) present, Assessment of senescence markers in skin, fat, and/or blood at baseline and day 14., Baseline, Day 14 | Change in proportion of senescent mesenchymal stem cells present, Assessment of senescence markers in mesenchymal stem cells at baseline and day 14., Baseline, Day 14|Change in mesenchymal stem cell function, Assessment of functional studies in mesenchymal stem cells at baseline and day 14. Number of subjects with change in stem cell function related to treatment., Baseline, Day 14|Change in Frailty index score, Assessment by Fried and other frailty criteria at baseline and day 14., Baseline, Day 14|Change in kidney function, Assessment by estimated and measured glomerular filtration rate at baseline, day 14, month 4, and month 12., Baseline, Day 14, Month 4, Month 12 | Mayo Clinic | ALL | ADULT, OLDER_ADULT | PHASE2 | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 15-005843 | 2016-07 | 2025-04 | 2025-04 | 2016-07-28 | 2024-04-19 | Mayo Clinic Florida, Jacksonville, Florida, 32224, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/31/NCT02848131/Prot_SAP_001.pdf | https://clinicaltrials.gov/study/NCT02848131 | |||||
| NCT02874989 | Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial | The study team hypothesizes that intermittent (3 doses administered over 3 consecutive days in 3 consecutive weeks) oral administration of combination Dasatinib (100 mg/d) + Quercetin (1250 mg/d) will be safe and well tolerated in patients with IPF. Treatment with D+Q will result in reduced abundance of pro-inflammatory cells within subjects over baseline. Finally, the reduction in biomarkers of cellular pro-inflammatory state will be related to no change in functional and patient reported outcomes. | IPF | COMPLETED | PMID: 30616998 | Idiopathic Pulmonary Fibrosis (IPF) | DRUG: Dasatinib + Quercetin|DRUG: Placebo | Percentage of pro-inflammatory expressing cells, A skin biopsy will be obtained at baseline and the percentage of pro-inflammatory expressing cells will be recorded, baseline|Percentage of pro-inflammatory expressing cells, A skin biopsy will be obtained at 4 weeks post baseline/5 days after the last dose of study medication and the percentage of pro-inflammatory expressing cells will be recorded, 4 weeks post baseline visit biopsy/ 5 days post last dose study drug|Blood Pressure, screening 1 week pre baseline visit|Blood Pressure, baseline visit|Blood Pressure, 4 weeks post baseline|Weight, screening 1 week pre baseline visit|Weight, baseline visit|Weight, 4 weeks post baseline|Heart Rate, screening 1 week pre baseline visit|Heart Rate, baseline visit|Heart Rate, 4 weeks post baseline|CBC (complete blood count), screening 1 week pre baseline visit|CBC (complete blood count), 4 weeks post baseline|Lipid Panel, screening 1 week pre baseline visit|Lipid Panel, 4 weeks post baseline|HbA1c (glycated hemoglobin), screening 1 week pre baseline visit|HbA1c (glycated hemoglobin), 4 weeks post baseline|CMP (comprehensive metabolic panel), screening 1 week pre baseline visit|CMP (comprehensive metabolic panel), 4 weeks post baseline|Plasma hsCRP (high-sensitivity C-reactive protein), screening 1 week pre baseline visit|Plasma hsCRP (high-sensitivity C-reactive protein), 4 weeks post baseline|Plasma IL-6 (inflammatory biomarker), baseline|Plasma IL-6 (inflammatory biomarker), 4 weeks post baseline|Plasma IL-6R (inflammatory biomarker), baseline|Plasma IL-6R (inflammatory biomarker), 4 weeks post baseline|Plasma PASP biomarkers (inflammatory biomarkers), baseline|Plasma PASP biomarkers (inflammatory biomarkers), 4 weeks post baseline|p16INK4a biomarker (inflammatory biomarker), baseline|p16INK4a biomarker (inflammatory biomarker), 4 weeks post baseline | Wake Forest University Health Sciences | Mayo Clinic|The University of Texas Health Science Center at San Antonio | ALL | ADULT, OLDER_ADULT | PHASE1 | 26 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE | IRB00037000 | 2016-12-16 | 2019-06-03 | 2019-06-03 | 2016-08-22 | 2020-05-12 | Wake Forest Baptist Health, Winston-Salem, North Carolina, 27157, United States|University of Texas Health Science Center, San Antonio, Texas, 78245, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/89/NCT02874989/ICF_000.pdf | https://clinicaltrials.gov/study/NCT02874989 | ||||
| NCT05362786 | Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease | The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease. | COMPLETED | Chronic Kidney Diseases | DRUG: Allogeneic adipose-derived mesenchymal stem cells (MSC)|DRUG: Allogeneic adipose-derived mesenchymal stem cells (MSC) | Adverse events and/or serious adverse events, Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention, 15 months|Change in eGFR Value, Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min), 6 months | LaTonya J. Hickson | ALL | ADULT, OLDER_ADULT | PHASE1 | 14 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT | 21-011822 | 2022-07-01 | 2024-07-24 | 2024-07-24 | 2022-05-05 | 2024-08-19 | Mayo Clinic Florida, Jacksonville, Florida, 32224, United States|Mayo Clinic Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT05362786 | ||||||||
| NCT03675724 | Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults | This is a pilot study to test the efficacy of the anti-inflammatory drug (Fisetin) in reducing inflammatory factors in blood in elderly adults and to test the efficacy of the drug (Fisetin) in reducing frailty and markers of inflammation, insulin resistance, and bone resorption in elderly adults. | AFFIRM-LITE | ENROLLING_BY_INVITATION | Frail Elderly Syndrome | DIETARY_SUPPLEMENT: Fisetin|DRUG: Placebo oral capsule | Decrease in blood inflammation markers, Percent decrease in blood inflammation markers, Seven Days | Mayo Clinic | ALL | OLDER_ADULT | PHASE2 | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 18-007332 | 2018-11-15 | 2025-10 | 2025-10 | 2018-09-18 | 2024-11-20 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT03675724 | |||||||
| NCT03325322 | Inflammation and Stem Cells in Diabetic and Chronic Kidney Disease | The proposed studies will examine the effect of fisetin on adipose tissue-derived mesenchymal stem/stromal cell function, kidney function, markers of inflammation, and physical function in individuals with advanced chronic kidney disease. | SUSPENDED | Chronic Kidney Diseases|Diabetes Mellitus|Diabetic Nephropathies | DIETARY_SUPPLEMENT: Fisetin|DRUG: Placebo oral capsule | Change in inflammatory markers including C-reactive protein, To examine the effect of study drug (compared to placebo) on markers of inflammation in skin, fat, plasma, and urine measured at baseline and day 14, 14 days|Effect on Mesenchymal stem cell function including cell migration, To examine the effect of study drug (compared to placebo) on mesenchymal stem cell function and vitality measured at baseline and day 14, 14 days | Effect on measures of Frailty including Fried Criteria, To examine the effect of study drug (compared to placebo) on markers of physical frailty (frailty phenotype)., 4 months|Kidney function including estimated glomerular filtration rate, To examine the effect of study drug (compared to placebo) on kidney function., 4 months|Kidney function including urine protein excretion rate, To examine the effect of study drug (compared to placebo) on kidney function protein excretion, 4 months|Number of participants with treatment-related adverse events including hospitalization, To assess the safety and tolerability of study drug taken over two days (compared to placebo), 12 months | Mayo Clinic | ALL | ADULT, OLDER_ADULT | PHASE2 | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | 16-010521 | 2018-01-02 | 2025-12 | 2026-12 | 2017-10-30 | 2024-04-19 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT03325322 | |||||||
| NCT04313634 | Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans | To determine if senolytic drugs reduce senescent cell burden and reduce bone resorption markers/increase bone formation markers in elderly women. | COMPLETED | Healthy | DRUG: Dasatinib|DRUG: Quercetin|DRUG: Fisetin | Change in C-terminal Telopeptide of Type I Collagen [CTX], Percent change in serum bone turnover markers C-terminal telopeptide of type I collagen \[CTX\]. The C-terminal telopeptide (CTX), also known as carboxy-terminal collagen crosslinks, is a biomarker used to measure the rate of bone turnover. It provides valuable information for assessing bone health and evaluating treatment responses., Baseline, 20 weeks | Change in Bone Turnover Markers, Percent change in amino-terminal propeptide of type I collagen (P1NP). The P1NP assay measures the serum concentration of the amino-terminal propeptide of type I procollagen (P1NP). As the concentration of this extension propeptide is directly proportional to the amount of new collagen laid down in bone, it can be used to assess bone formation., Baseline, 2 weeks|Change in Bone Turnover Markers, Percent change in amino-terminal propeptide of type I collagen (P1NP). The P1NP assay measures the serum concentration of the amino-terminal propeptide of type I procollagen (P1NP). As the concentration of this extension propeptide is directly proportional to the amount of new collagen laid down in bone, it can be used to assess bone formation., Baseline, 4 weeks|Change in Bone Turnover Markers, Percent change in amino-terminal propeptide of type I collagen (P1NP). The P1NP assay measures the serum concentration of the amino-terminal propeptide of type I procollagen (P1NP). As the concentration of this extension propeptide is directly proportional to the amount of new collagen laid down in bone, it can be used to assess bone formation., Baseline, 20 weeks|Change in Bone Mineral Density (BMD), Percent change in BMD by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, hip ((total and femoral neck (FN), and radius (total and ultra-distal))., Baseline, 20 weeks|Change in Plasma Senescence-associated Secretory Phenotype (SASP), Percent change in SASP cells (representing the total senescence cell burden) present. Assessment of senescence markers in bone at baseline and 2 weeks., Baseline, 2 weeks | Sundeep Khosla, M.D. | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 74 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 18-010546 | 2020-06-09 | 2023-06-06 | 2023-06-06 | 2020-03-18 | 2024-07-22 | 2024-07-22 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/34/NCT04313634/Prot_SAP_000.pdf | https://clinicaltrials.gov/study/NCT04313634 | |||||
| NCT04537299 | COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes | The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction. | COVID-FIS | COMPLETED | PMID: 34375437 | Covid19|SARS-CoV Infection | DRUG: Fisetin|DRUG: Placebo | Change in COVID-19 Severity, Ordinal Scale for Clinical Improvement (minimum=0 and maximum=8; higher score = worse outcome), baseline, Day 2, 7, 10, 14, 17, 30, 90 and 180 | Mayo Clinic | National Institute on Aging (NIA) | ALL | OLDER_ADULT | PHASE2 | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 20-008867|1R01AG072301-01 | 2022-04-29 | 2024-08-31 | 2024-11-30 | 2020-09-03 | 2025-03-25 | Mayo Clinic, Rochester, Minnesota, 55905, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/99/NCT04537299/ICF_000.pdf | https://clinicaltrials.gov/study/NCT04537299 | ||||
| NCT03430037 | Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women | This is a pilot study to evaluate whether targeting inflammation will help reduce markers of insulin resistance inflammation, bone resorption and physical dysfunction in elderly women with gait disturbance. Positive results of this study would lead to the development of a larger clinical trial examining the effects of this intervention on age-related dysfunction. | AFFIRM | ENROLLING_BY_INVITATION | Frail Elderly Syndrome | DIETARY_SUPPLEMENT: Fisetin|DRUG: Placebo oral capsule | Improved 6 minute walk, Improved gait speed, One Month | Mayo Clinic | FEMALE | OLDER_ADULT | PHASE2 | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 17-000472 | 2018-02-06 | 2025-10 | 2025-10 | 2018-02-12 | 2024-11-25 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT03430037 | |||||||
| NCT05758246 | Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial | The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway. A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial. | RECRUITING | Sepsis|Acute Infection|Organ Failure | DRUG: Fisetin-dose 1|DRUG: Fisetin-dose 2|DRUG: Placebo | Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA), The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. This outcome assesses only the cardiovascular, respiratory, and renal categories of the total SOFA score, and calculates the change from day 0 to day 7., day 7 | Safety of 2 doses of fisetin in patients with mild sepsis, Outcome is the number of serious adverse event, day 28|Organ failure free days, Outcome is 28 days minus the last day the patient required any of the following: ventilator support, vasopressors, or dialysis / renal replacement therapy. Patients who die prior to day 28 are given a value of -1., day 28|Total SOFA score, The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category., day 7|Zubrod performance status, A scale for indicating a patient's functional level: 0 asymptomatic - 1 Symptomatic, fully ambulatory - 2 Symptomatic, in bed - 50% of the day - 3 Symptomatic, in bed; 50% of the day but not bedridden - 4 Bedridden - 5 Dead., day 7|SF-12 score, The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual 39;s everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher., day 7|SF-12 score, The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual 39;s everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher., day 28|Zubrod performance status, A scale for indicating a patient's functional level: 0 asymptomatic - 1 Symptomatic, fully ambulatory - 2 Symptomatic, in bed - 50% of the day - 3 Symptomatic, in bed; 50% of the day but not bedridden - 4 Bedridden - 5 Dead., day 28|Days in the ICU, This outcome is the number of days the patient was admitted to the ICU., day 28|All-cause mortality, This outcome is the proportion of patients suffering all-cause mortality prior to day 28., Day 28|Peripheral CD3+ senescent (SnCs) immune cells, Outcome is the relative expression of p16Ink4a in CD3+ cells., day 7|Outcome is the relative expression of p16Ink4a in CD3+ cells., Outcome is the relative expression of p16Ink4a in CD3+ cells., day 28|TNF-alpha, Outcome is the concentration of TNF-alpha by Luminex human discovery assay, day 7 | University of Minnesota | ALL | OLDER_ADULT | PHASE2 | 220 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | HRP-XXX | 2023-08-23 | 2026-08-23 | 2026-08-23 | 2023-03-07 | 2025-03-25 | University of Florida, Gainesville, Florida, 32608, United States|University of Iowa, Iowa City, Iowa, 52242, United States|Ridges, Burnsville, Minnesota, 55337, United States|Southdale, Edina, Minnesota, 55435, United States|M Health Fairview St. John's, Maplewood, Minnesota, 55109, United States|St. John's, Maplewood, Minnesota, 55109, United States|University of Minnesota, Minneapolis, Minnesota, 55414, United States|HCMC, Minneapolis, Minnesota, 55415, United States|UMMC, Minneapolis, Minnesota, 55455, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States | https://clinicaltrials.gov/study/NCT05758246 | |||||||
| NCT02652052 | Hematopoietic Stem Cell Transplant Survivors Study | The investigators hope to find the proof of principle concept from this pilot study so that the investigators can design a clinical trial based on the results of the explanatory hypothesis. | COMPLETED | Stem Cell Transplant | OTHER: Standard of Care - Observation Only|DRUG: Group 2: Quercetin|DRUG: Group 2: Dasatinib | Frailty, Evaluate the association of frailty with measures of senescence in HSCT survivors - level of frailty as assessed by FRIED, Up to 180 days | Mayo Clinic | ALL | ADULT, OLDER_ADULT | PHASE1 | 9 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 15-004683|NCI-2021-14235 | 2016-03-01 | 2023-05-23 | 2023-05-23 | 2016-01-11 | 2025-03-25 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT02652052 | ||||||||
| NCT04785300 | ALSENLITE: Senolytics for Alzheimer's Disease | This study is being done to evaluate the safety and feasibility of using Dasatinib and Quercetin together in subjects with Mild Cognitive Impairment (MCI) or Alzheimer's disease. | ENROLLING_BY_INVITATION | PMID: 34366147 | Mild Cognitive Impairment|Alzheimer Disease | DRUG: Dasatinib|DRUG: Quercetin | Safety and Tolerability, Safety evaluations will be conducted including assessment for adverse events, compliance to the study drug regimen, physical examinations or assessments, vital signs, and laboratory assessments., 11 weeks | Mayo Clinic | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 19-003394 | 2022-07-06 | 2026-06 | 2026-06 | 2021-03-05 | 2025-03-25 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT04785300 | |||||||
| NCT04210986 | Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial | Phase I/II randomized, double-blind, placebo-controlled clinical trial to test the safety and efficacy of Fisetin for treating mild to moderate osteoarthritis | COMPLETED | Osteoarthritis, Knee | DIETARY_SUPPLEMENT: Fisetin|DRUG: Placebo oral capsule | Number of Participants Experiencing One or More Treatment-Emergent Adverse Event, Number of Participants Experiencing one or more Treatment-Emergent Adverse Event (TEAE) within each group., Duration of study, an average of 12 months | Change in Levels of Pro-inflammatory Markers Associated With Senescence, Serum C-reactive protein (CRP) level measured on ELISA. The enzyme linked immunoassay (ELISA) is a laboratory technique that detects certain antigens in the blood. ELISA was used to detect the level of CRP in the blood. The liver releases CRP into blood in response to inflammation. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 14 days, 45 days, 6 months, 12 months (post 1st drug dose)|Change in Levels of Cartilage Degenerating Markers Associated With OA, Serum cartilage oligomeric matrix protein (COMP) level measured on ELISA. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 14 days, 45 days, 6 months, 12 months (post 1st drug dose)|Change in Physical Function of the Study Knee (6 Min Walk), The 6 minute walk test (6MWT) assesses distance (in meters) walked over 6 minutes as a sub-maximal test of aerobic capacity, exercise tolerance and endurance. The score range for healthy adults is 400-700 m, depending on age and sex. Shorter distances indicate increased impairment. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, and 12 months (post 1st drug dose)|Change in Physical Function of the Study Knee (Timed-up-and-go Test), The Timed Up and Go (TUG) test measures how long it takes (in seconds) to stand up, walk a distance of 10 feet, turn, walk back, and sit down again. \< 10 seconds is considered normal. Longer times indicate poorer function. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, and 12 months (post 1st drug dose)|Change in Physical Function of the Study Knee (Fast 4-meter Walk), fast 4-meter walk test (4MW). The 4MW was assessed at the fastest safe speed for each participant. This test assesses the capacity for performance of certain activities (e.g., crossing a street before the light changes). Units are m/s, and slower speeds indicate greater impairment. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, and 12 months (post 1st drug dose)|Change in Physical Function of the Study Knee (LEK), Peak knee adduction moment (KAM) during stance phase of gait in the affected leg, determined using video-motion analysis and force plate data. Values are normalized by mass\*height of participant. Higher KAM has been associated with more rapid osteoarthritis progression. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, and 12 months (post 1st drug dose)|Change in Physical Function of the Study Knee (Stair-Climbing Test), The Stair-Climbing Test assesses the time required (in seconds) to ascend and descend a standard flight of 10 stairs. Longer times indicate poorer physical function. Stairs require greater knee extensor force than gait, so this test may be more sensitive to osteoarthritis pain and function than walking tests. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, and 12 months (post 1st drug dose)|Change in Muscle Strength (Isokinetic Dynamometry), This test utilizes an isokinetic dynamometer to assess the peak knee extension torque that can be produced by the affected leg at a constant rate of knee extension (60 degrees/s). The resulting measure is normalized by body mass and reported with units Newton-meters (Nm). Increased torque over time would indicate improved muscle strength and/or decreased joint pain. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, and 12 months (post 1st drug dose)|Evaluation of Patient Reported Outcomes (PROs) for Knee Pain, Numeric Rating Scale (NRS) reporting 'pain today'. Scale of 0-10 with 0 representing 'no pain' and 10 representing 'severe pain'. All post-intervention group comparisons were adjusted for the baseline value as a covariate., every 3 days for the first 6-weeks of drug dosing, then weekly for an additional 6 weeks.|Evaluation of Patient Reported Outcomes (PROs) for Knee Function, Western Ontario and McMaster Universities Arthritis Index (WOMAC) - total score. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function. All post-intervention group comparisons were adjusted for the baseline value as a covariate., 6 months, 12 months, and 18 months (post 1st drug dose)|Change in the Quality of Articular Cartilage in the Study Knee With Quantitative Magnetic Resonance Imaging (MRI), Mean T2 relaxation times were determined across 4 subregions: central medial femur (CMF), central lateral femur (CLF), central medial tibia (CMT), and central lateral tibia (CLT). All post-intervention group comparisons were adjusted for the baseline value as a covariate. The mean T2 changes over time for all subregions were listed in rank order from most positive (indicating worsened cartilage condition over time) to most negative (indicating improved cartilage condition over time). These unitless rankings were used in a Sum of Ranks statistical analysis to compare cartilage changes across different knee joint regions without assuming normality (as appropriate for MRI data). There are no published standards for what would be considered a clinically significant effect for sum-of-ranks cartilage T2 data, so it was assumed that a statistically significant difference would imply clinical significance as well., 6 months, and 12 months (post 1st drug dose)|Number of Participants Who Convert to Alterative Treatment Within Each Group., Patients will be allowed to receive a steroid injection and still participate in the study. All participants that undergo alternative therapy (e.g. total knee arthroplasty or biologic injection) will be recorded, and proportions will be compared between groups., Any time during 18-month monitoring period. | Steadman Philippon Research Institute | United States Department of Defense|Office of Naval Research (ONR) | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 75 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 2019-16 | 2020-01-06 | 2023-01-05 | 2023-02-01 | 2019-12-26 | 2024-09-19 | 2024-09-19 | The Steadman Clinic, Vail, Colorado, 81657, United States | Study Protocol, Statistical Analysis Plan, and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/86/NCT04210986/Prot_SAP_ICF_002.pdf | https://clinicaltrials.gov/study/NCT04210986 | ||||
| NCT04733534 | An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer | This is a first-in survivor pilot study with the goal of establishing preliminary evidence of efficacy, safety, and tolerability of two senolytic regimens to reduce markers of cellular senescence (primary outcome: p16\^INK4a) and improve frailty (primary outcome: walking speed) in adult survivors of childhood cancer. If successful, this pilot would provide the preliminary evidence needed for a phase 2, randomized, placebo-controlled trial to establish efficacy. Primary Objective * The primary aim of this proposal is to test the efficacy of two, short duration senolytic regimens: 1) combination of Dasatinib plus Quercetin and 2) Fisetin alone, to improve walking speed and decrease senescent cell abundance in blood (p16\^INKA): * Primary endpoints of this trial will be change in walking speed and senescent cell abundance in blood (p16\^INK4A) determined at baseline and again at 60 days, within an individual arm. Extended follow up at 150 days will assess the permanence of change after completion of the trial. Secondary endpoints of this trial will be effect of intervention on additional measures of frailty (beyond walking speed; Fried criteria) and on other cell senescence markers, markers of inflammation, insulin resistance, bone resorption, and cognitive function. Secondary Objectives The secondary aim is to test the safety and tolerability of two different senolytic therapies. Exploratory Objectives * To compare the efficacy of the two senolytic regimens in improving walking speed and decreasing senescent cell abundance * To evaluate the longitudinal pattern in measures of frailty. | RECRUITING | Frailty|Childhood Cancer | DRUG: Dasatinib plus Quercetin|DRUG: Fisetin | Change in walking speed, Walking speed will be measured by having the participant walk 4 meters as fast as he/she can walk. This test will be measured in meters per second., Baseline|Change in Walking Speed, Walking speed will be measured by having the participant walk 4 meters as fast as he/she can walk. This test will be measured in meters per second., Day 30|Change in Walking Speed, Walking speed will be measured by having the participant walk 4 meters as fast as he/she can walk. This test will be measured in meters per second., Day 60|Change in Walking Speed, Walking speed will be measured by having the participant walk 4 meters as fast as he/she can walk. This test will be measured in meters per second., Day 150|Senescent cell abundance in blood (p16INK4A), Following a 12 hour overnight fast, 10 ml blood will be collected in EDTA tubes, processed at St. Jude and shipped to the Kirkland lab for evaluation of CD3+ peripheral blood T lymphocytes (PTBL) p16INK4A mRNA, a biomarker of senescence and chronological aging. CD3+ PTBL will be isolated from whole blood using Whole Blood CD3 Human Microbeads (Miltenyi Biotec, Cat# 130-090-874) by MACS sorting \[79\]. CD3+ cells will be lysed, mRNA isolated, and p16INK4A expression assayed by RT-PCR using a Taq-man primer-probe system., Baseline|Senescent cell abundance in blood (p16INK4A), Following a 12 hour overnight fast, 10 ml blood will be collected in EDTA tubes, processed at St. Jude and shipped to the Kirkland lab for evaluation of CD3+ peripheral blood T lymphocytes (PTBL) p16INK4A mRNA, a biomarker of senescence and chronological aging. CD3+ PTBL will be isolated from whole blood using Whole Blood CD3 Human Microbeads (Miltenyi Biotec, Cat# 130-090-874) by MACS sorting \[79\]. CD3+ cells will be lysed, mRNA isolated, and p16INK4A expression assayed by RT-PCR using a Taq-man primer-probe system., Day 7|Senescent cell abundance in blood (p16INK4A), Following a 12 hour overnight fast, 10 ml blood will be collected in EDTA tubes, processed at St. Jude and shipped to the Kirkland lab for evaluation of CD3+ peripheral blood T lymphocytes (PTBL) p16INK4A mRNA, a biomarker of senescence and chronological aging. CD3+ PTBL will be isolated from whole blood using Whole Blood CD3 Human Microbeads (Miltenyi Biotec, Cat# 130-090-874) by MACS sorting \[79\]. CD3+ cells will be lysed, mRNA isolated, and p16INK4A expression assayed by RT-PCR using a Taq-man primer-probe system, Day 30|Senescent cell abundance in blood (p16INK4A), Following a 12 hour overnight fast, 10 ml blood will be collected in EDTA tubes, processed at St. Jude and shipped to the Kirkland lab for evaluation of CD3+ peripheral blood T lymphocytes (PTBL) p16INK4A mRNA, a biomarker of senescence and chronological aging. CD3+ PTBL will be isolated from whole blood using Whole Blood CD3 Human Microbeads (Miltenyi Biotec, Cat# 130-090-874) by MACS sorting \[79\]. CD3+ cells will be lysed, mRNA isolated, and p16INK4A expression assayed by RT-PCR using a Taq-man primer-probe system., Day 60|Senescent cell abundance in blood (p16INK4A), Following a 12 hour overnight fast, 10 ml blood will be collected in EDTA tubes, processed at St. Jude and shipped to the Kirkland lab for evaluation of CD3+ peripheral blood T lymphocytes (PTBL) p16INK4A mRNA, a biomarker of senescence and chronological aging. CD3+ PTBL will be isolated from whole blood using Whole Blood CD3 Human Microbeads (Miltenyi Biotec, Cat# 130-090-874) by MACS sorting \[79\]. CD3+ cells will be lysed, mRNA isolated, and p16INK4A expression assayed by RT-PCR using a Taq-man primer-probe system., Day 150 | Safety of two different senolytic therapies as assessed by treatment-related adverse events using CTCAE v5.0, To test the safety of the combination of Dasatinib plus Quercetin or Fisetin alone, 150 days|Tolerability of two different senolytic therapies as assessed by treatment-related adverse events using CTCAE v5.0, To test the tolerability of the combination of Dasatinib plus Quercetin or Fisetin alone, 150 days | St. Jude Children's Research Hospital | National Institutes of Health (NIH)|National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE2 | 120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | SENSURV|U01CA246510 | 2022-06-06 | 2026-12 | 2027-12 | 2021-02-02 | 2025-03-25 | St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States | https://clinicaltrials.gov/study/NCT04733534 | ||||||
| NCT05416515 | A Study of Fisetin to Treat Carpal Tunnel Syndrome | This research study is being conducted to investigate the safety and effectiveness of the drug Fisetin for mild or moderate carpal tunnel syndrome (CTS). | ACTIVE_NOT_RECRUITING | Carpal Tunnel Syndrome | DRUG: Fisetin | Change in CTS symptoms, Measured using the self-reported Boston Carpal Tunnel Syndrome questionnaire (BCTQ) score to assess symptoms severity and overall function of subjects with CTS. Questionnaire consist of 11 questions for symptoms severity and 8 questions for function on a 1-5 point scale for each question; higher scores indicate greater severity and dysfunction., Baseline, 60 days | percent decrease in blood markers of cellular senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and additional exploratory, novel assays, Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence, Baseline, 60 days|percent decrease in blood markers of cellular senescence in long-term, percent decrease in blood markers of cellular senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and additional exploratory, novel assays, Baseline, 180 days | Peter C. Amadio, M.D. | ALL | ADULT, OLDER_ADULT | PHASE2 | 40 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 21-010406 | 2022-10-09 | 2024-12-31 | 2025-12 | 2022-06-13 | 2025-03-25 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT05416515 | |||||||
| NCT04063124 | Senolytic Therapy to Modulate Progression of Alzheimer's Disease | The purpose of this pilot study is to evaluate whether a combination of two drugs, dasatinib (D) and quercetin (Q) \[D+Q\], penetrate the brain using cerebrospinal fluid (CSF) in older adults with early Alzheimer's disease (AD). This combination of drug therapy has been shown to affect dying cells in humans with other chronic illnesses and in Alzheimer's mice models. The study team want to know if this combination of medications will reach the brain in order to evaluate if this intervention may be effective for treating AD symptoms in future studies. This is also known as a "proof of concept" study. | SToMP-AD | COMPLETED | PMID: 34687726 PMID: 35098970 | Alzheimer Disease | DRUG: Dasatinib + Quercetin | Brain Penetrance of Dasatinib (D), Cerebrospinal Fluid (CSF) collected by lumbar puncture before and after 12 weeks of treatment to determine levels of drug that reach the central nervous system will be measured by high performance liquid chromatography/mass spectrometry (HPLC/MS), Change from 0 to 12 weeks|Brain Penetrance of Quercetin (Q), CSF collected by lumbar puncture before and after 12 weeks of treatment to determine levels of drug that reach the central nervous system using HPLC/MS, Change from 0 to 12 weeks | Alzheimer's Disease Marker - CSF Tau, Cerebrospinal Fluid collected by lumbar puncture analyzed for level of tau proteins present in CSF, Change from 0 to 12 weeks|Alzheimer's Disease Marker - CSF Amyloid Beta, Cerebrospinal Fluid collected by lumbar puncture analyzed for level of amyloid beta proteins present in CSF, Change from 0 to 12 weeks|Senescence Marker IL-6 in CSF, Laboratory measure of level of IL-6 found in CSF collected pre and post treatment, Change from 0 to 12 weeks|Senescence Marker P16 in CSF, Laboratory measure of level of P16 found in CSF collected pre and post treatment, Change from 0 to 12 weeks|Electronic Gait Mapping Under Single and Dual-task Conditions, Participants walk on a pressure-sensitive walkway to capture data on gait speed, Change from 0 to 12 weeks|Montreal Cognitive Assessment (MoCA), A test which scores the participant with score ranges between 0 and 30. A score of 26 or over is considered normal. Individuals with mild cognitive impairment score lower and individuals with Alzheimer's disease score even lower., Change from 0 to 12 weeks | The University of Texas Health Science Center at San Antonio | Mayo Clinic | ALL | OLDER_ADULT | PHASE1|PHASE2 | 5 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | HSC20190222H | 2020-02-14 | 2021-12-10 | 2023-01-30 | 2019-08-21 | 2023-03-06 | 2023-03-06 | Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases, San Antonio, Texas, 78229, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/24/NCT04063124/Prot_SAP_000.pdf | https://clinicaltrials.gov/study/NCT04063124 | ||
| NCT03840343 | Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease | The Researchers will assess the safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose (fat) tissue-derived mesenchymal stem/stromal cells (MSC) in patients with progressive diabetic kidney disease (DKD). | TERMINATED | Diabetic Kidney Disease|Diabetic Nephropathies|Diabetes Mellitus, Type 2|Diabetes Mellitus, Type 1|Chronic Kidney Disease|Diabetic Nephropathy Type 2|Kidney Failure|Kidney Insufficiency | BIOLOGICAL: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose|BIOLOGICAL: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose | Adverse Events, The number of Adverse Events associated with MSC intervention per treatment arm, Baseline through Month 15|Adverse Events, The percentage of Adverse Events associated with MSC intervention per treatment arm, Baseline through Month 15 | Kidney Function, Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA, baseline, month 6|Kidney Function, Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m\^2/month, pretreatment, month 12 | Mayo Clinic | Regenerative Medicine Minnesota | ALL | ADULT, OLDER_ADULT | PHASE1 | 2 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 18-002423|RMM 091718 CT 001 | 2019-10-23 | 2020-08-04 | 2020-08-04 | 2019-02-15 | 2023-04-05 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT03840343 | ||||||
| NCT04869761 | Stem Cell Therapy for Chronic Kidney Disease | The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease. | ACTIVE_NOT_RECRUITING | Chronic Kidney Diseases|Diabetes Mellitus, Type 2|Diabetes Mellitus, Type 1|Diabetes Mellitus|Diabetic Nephropathies | DRUG: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion|DRUG: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions | Adverse events and/or serious adverse events, Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention, 22 months | LaTonya J. Hickson | ALL | ADULT, OLDER_ADULT | PHASE1 | 10 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | 20-008380 | 2021-10-07 | 2026-12 | 2026-12 | 2021-05-03 | 2025-03-25 | Mayo Clinic Florida, Jacksonville, Florida, 32224, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT04869761 | ||||||||
| NCT03818802 | Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging | Researchers are trying to determine if the vitamin B3 derivative Nicotinamide Riboside (NR) has any effects in bone, skeletal muscle, and metabolic functions and structure in aging. | COMPLETED | Healthy Elderly Volunteers | DIETARY_SUPPLEMENT: Nicotinamide Riboside|DIETARY_SUPPLEMENT: Placebo | Maximal oxygen uptake (VO2 max) test, Maximal oxygen uptake (VO2 max) test measures the maximum rate of oxygen consumption during incremental exercise (exercise of increasing intensity) and reflects the cardiorespiratory fitness of an individual and is an important determinant of their endurance capacity during prolonged exercise., 6 months|Skeletal muscle function, The 6-minute walk test (6MWT) quantifies the distance a person can walk in six minutes and will be used to document the mobility/functional status of a patient. Originally developed to evaluate the physical capacity of patients with cardiopulmonary diseases, the test has been used to assess treatment effects, physical function status, and to predict morbidity and mortality in several patient populations including frail older adults., 6 months|Short Physical Performance Battery (SPPB), The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability., 6 months|Respiration rate on muscle biopsy samples, The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers, 6 months|PCR on muscle biopsy samples, RT-PCR for gene expression, 6 months|Immunoblot on muscle biopsy samples, Immunoblot in skeletal lysates for protein expression, 6 months|Bone metabolism, Serum Carboxy-terminal Telopeptide (CTX), tartrate-resistant acid phosphatase isoform type 5b (TRAP5b), Amino-terminal Pro-peptide (P1NP), and osteocalcin will all be measured to monitor bone turnover markers., 6 months | Glucose profile, Serum glucose measure, 6 months|Insulin, Serum insulin measure, 6 months|Lipid profile, Blood cholesterol measure, 6 months|Hemoglobin A1C, Hb A1C measure in blood sample, 6 months|Oral glucose tolerance test, An 18-gauge cannula will be inserted in a retrograde fashion into a dorsal hand vein of the non-dominant arm. The hand will be placed in a heated box (55°C) to enable sampling of arterialized venous blood. Blood will be drawn at 0 (baseline), 10, 20, 30, 60, 90, and 120 minutes for the measurement of glucose, insulin, and C-peptide concentrations. After the baseline blood draw, subjects will ingest 75 g of glucose over a period of 5 minutes., 6 months | Mayo Clinic | FEMALE | OLDER_ADULT | NA | 53 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION | 18-000224 | 2019-09-16 | 2024-11-08 | 2024-11-08 | 2019-01-28 | 2025-03-25 | Mayo Clinic, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT03818802 | |||||||
| NCT05595499 | Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors | This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer. | RECRUITING | Anatomic Stage I Breast Cancer AJCC V8|Anatomic Stage II Breast Cancer AJCC V8|Anatomic Stage III Breast Cancer AJCC V8 | PROCEDURE: Biospecimen Collection|DRUG: Fisetin|DRUG: Placebo Administration|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Change in 6-minute walk distance (6MWD), The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups., Baseline to day 60 | Change in grip strength, Generalized estimating equation (GEE) models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to access change in grip strength. Grip strength will be obtained using a hand dynamometer., From baseline to day 60|Change in Short Physical Performance Battery score, GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to access change in short physical performance battery score., From baseline to day 60|Change in frailty phenotype, GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in physical function component of 36-item Short Form (SF-36), GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in the Borg Rating of Perceived Exertion score, GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 scores, GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in Patient Reported Outcomes Measurement Information System cognitive function short form score, GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in composite SF-36 score, GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in sleep (Insomnia Severity Index score), GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in anxiety (Generalized Anxiety Disorder-7 score), GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Change in depression (Patient Health Questionnaire-8 score), GEE models will be fitted. The variables also will be dichotomized (e.g., \< median, \>= median) and GEE models for binary data used to test treatment effects over time., From baseline to day 60|Local recurrence free survival, Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method., Up to 3 years|Distant recurrence free survival, Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method., Up to 3 years|Breast cancer specific survival and overall survival, Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method., Up to 3 years|Overall survival, Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method., Up to 3 years|Adverse events rates, Measured by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5. Adverse events will be determined at each time point per patient as the presence (yes/no) of toxicities (CTCAE v 5.0) of grade \>= 2. The number of patients with adverse events will be compared by treatment arms using Fisher's exact test. GEE models for binary data will also be used to compare the proportion of patients with adverse events over time by treatment., Up to 90 days|Adherence rate, Measured by pill diary. Treatment adherence (yes/no) for each patient at each time point will be determined. A patient will be considered adherent (coded 1) if she took all the required capsules within the allotted time, and non-adherent (coded 0) otherwise. The number of capsules taken in the allotted time out of the total required will also be recorded. Will then compare between treatments the proportion of adherent patients and the average proportion of capsules taken within the allotted time across patients at each time point using the t-test. Time point-specific analysis will be performed since conditions for pill-taking differ between the clinic (supervised) and patients' home (self-administered)., From baseline up to 30 days | Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI)|National Institute on Aging (NIA) | FEMALE | CHILD, ADULT, OLDER_ADULT | PHASE2 | 88 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 23-001170|NCI-2022-08061|P30CA016042|R21CA277660|K76AG074918 | 2023-03-27 | 2026-06-01 | 2026-06-01 | 2022-10-27 | 2025-03-25 | UCLA Health Cancer Care in Alhambra, Alhambra, California, 91801, United States|UCLA Health Beverly Hills Primary & Specialty Care, Beverly Hills, California, 90210, United States|UCLA Health Burbank Primary & Specialty Care, Burbank, California, 91505, United States|City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States|UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|UCLA Health Primary Care in Marina del Rey, Marina del Rey, California, 90292, United States|UCLA Health Primary Care in Pasadena, Pasadena, California, 91105, United States | https://clinicaltrials.gov/study/NCT05595499 | ||||||
| NCT04815902 | Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis | This is a prospective, randomized, double-blind, active control clinical trial to evaluate the safety and efficacy of a senolytic agent (Fisetin) and an anti-fibrotic agent (Losartan), used independently and in combination, to improve beneficial effect demonstrated by the active control which is to be injection of autologous bone marrow aspirate concentrate (BMAC) into an osteoarthritic knee. | ACTIVE_NOT_RECRUITING | Osteoarthritis, Knee | DRUG: Fisetin|DRUG: Losartan|DRUG: Placebo - Losartan|DRUG: Placebo Fisetin | Incidence of Treatment-Emergent Adverse Events, Occurrence of adverse events, Adverse events will be collected from the date of BMAC injection to 12 months after injection | Morphological and Quantitative Magnetic Resonance Imaging (MRI), Cartilage quality assessed by blinded radiologist using morphological MRI. Quantitative MRI using T2 mapping images with texture analysis used to assess water content and collagen organization within the cartilage and surrounding tissue, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection)|Evaluation of patient reported outcome (PRO) for quality of life, 12-question Short-Form General Health Survey (SF-12) - Including Physical Component Summary (PCS) and Mental Component Summary (MCS)., within 3 months of injection, 32 days post baseline, 14 days post injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection, 18 months post injection|Evaluation of patient reported outcome (PRO) for knee functions (WOMAC), The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (24 questions; rated none, mild, moderate, or severe. Higher WOMAC score represents higher disability), within 3 months of injection, 32 days post baseline, 14 days post injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection, 18 months post injection|Evaluation of patient reported outcome (PRO) for knee functions (Tegner), Tegner Physical Activity Scale (1 question; scale of 0 to10; 0 representing a low activity level and 10 representing a high activity level), within 3 months of injection, 32 days post baseline, 14 days post injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection, 18 months post injection|Evaluation of patient reported outcome (PRO) for knee functions (IKDC), International Knee Documentation Committee (IKDC) Form. (scores range from 0 points or lowest level of function, to 100 points or highest level of function), within 3 months of injection, 32 days post baseline, 14 days post injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection, 18 months post injection|Patient-Reported Outcome Questionnaires, Numerical Rating Scale (NRS) for knee pain (6 questions with a scale of 0 to 10; 0 representing no pain and 10 representing extreme pain), Screening, weekly post 1st study drug dose (pre-injection), weekly post injection (for 4 months)|Change in muscle strength of the study knee, Isokinetic Dynamometry, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection|Change in physical function of the Study Knee (LEK), Lower Extremity Kinematics, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection|Change in physical function of the Study Knee (Stair Test), Stair Test, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection]|Change in physical function of the Study Knee (fast 40-meter walk), Fast 40-meter walk, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection|Change in physical function of the Study Knee (TUG), Timed up-and-go test, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection|Change in physical function of the Study Knee (6-minute walk test), 6-minute walk test, 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection]|Change in associate biomarkers as compared to placebo in peripheral blood plasma/serum, Immunoassays for Biomarker assessment from blood serum. Analytes will be measured via immunoassays. The following analytes will be measured and reported in pg/ml. IL-1b, IL-6, IL-15, IL-1a, IL-1Ra, IL-7, IL-8, MCP-1, TNF-a , RANTES, VEGF, IFN-g, GRO, IP10, Eotaxin, PDGF-AA, PDGFAB-BB, EGF, FLT3L, GDF15, GDF11, FGF21, IL-18, SOST, OC, FGF-23, PTH, Leptin, Insulin, TIMP1, TIMP2, TGF-b1, TGF-b2, MMP-1, MMP-2, MMP-9, MMP-10, HA, COMP, CS846, CRP., screening, 14 days post-injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection|Change in CTX-II as compared to placebo in urine, Immunoassays for CTX-II detection in urine reported as pg/ml, 32 days post baseline, 6 months post injection, 12 months post injection|Change in levels of senescent PBMCS (total and specific PBMC subsets such as T-Cells), Flow Cytometry based detection and quantification of senescent PBMCs isolated from whole blood. Intensity of the fluorescent marker C12FDG will be measured. Cells positive for C12FDG will be quantified and designated as senescent., screening, 14 days post-injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection|Change in synovial fluid content, Synovial Fluid Analysis, 32 days post baseline, 6 months post injection, 12 months post injection|Characterization of Bone Marrow Derived Aspirate Concentrate cell content prior to injection, BMAC Analysis, 32 days post baseline|Characterization of Bone Marrow Derived plasma biomarkers prior to injection, BMAC Analysis, 32 days post baseline|Change in time to conversion to alternative treatment, Alternative procedure as indicated. The time to resort to alternative therapy from baseline will be recorded, Subjects may receive alternative treatment at any point during the 18-month study, continued participation will be determined on an individual basis (The time to resort to alternative therapy from baseline will be recorded) | Steadman Philippon Research Institute | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 100 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 2020-15|1UG3AR077748-01 | 2021-05-18 | 2025-02-01 | 2025-06-01 | 2021-03-25 | 2024-04-16 | The Steadman Clinic, Vail, Colorado, 81657, United States | https://clinicaltrials.gov/study/NCT04815902 | ||||||
| NCT04685590 | Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD) Study | The objective of the study is to determine the safety, feasibility, and efficacy of senolytics in older adults with amnestic mild cognitive impairment (MCI) or early-stage AD (Clinical Dementia Rating (CDR)=0.5 or 1) who are tau PET positive | SToMP-AD | ACTIVE_NOT_RECRUITING | PMID: 34366147 PMID: 34687726 | Alzheimer Disease, Early Onset|Mild Cognitive Impairment | DRUG: Dasatinib + Quercetin|OTHER: Placebo Capsules | Serious Adverse Events (SAEs) and Adverse Events (AEs) in treatment group as compared to placebo group, Adverse Events (AEs) and SAEs will be collected at each in-person visit and at scheduled telephone visits from baseline to week 48. Incidence of SAEs between groups (treatment vs. placebo) will be reviewed by the Data Safety Monitoring Board (DSMB) for clinical significance., Baseline to Week 48 | Change in cellular senescence blood marker Senescence-Associated Secretory Phenotype (SASP) composite score, Composite score (average z-score of log-transformed values) of ten primary SASP factors measured in blood., Baseline to Week 12|Change in cellular senescence blood marker Cluster of Differentiation 3 (CD3) in blood, Primary markers of cellular senescence CD3 measured in blood., Baseline to Week 12|Change in cellular senescence blood marker cyclin-dependent kinase inhibitor 2A (p16INK4A+) in blood, Primary markers of cellular senescence p16INK4A+ measured in blood., Baseline to Week 12|Change in cellular senescence blood marker T cells in blood, Primary markers of cellular senescence T cells measured in blood., Baseline to Week 12|Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) slope, CDR is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2), and severe cognitive impairment (CDR = 3). The six domains are often summed to create a 0 - 18 "sum of the boxes" score. CDR-SB has been shown to demonstrate sensitivity to cognitive changes associated with progression of amnestic mild cognitive impairment (aMCI) and early Alzheimer's Disease (AD)., Baseline to Week 48|Change in the 14 - item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 14) slope, A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 65 (worse), and are added to the mean of the words not immediately recalled (max of 10) and the number of items not recalled after a delay (ranging from 0-10) all total the maximum score of 85. A positive change indicates cognitive worsening., Baseline to Week 48|Change in Positron Emission Tomography (PET) - Computed Tomography (CT) - brain tau pathology, Tau levels in the brain will measured by 18F AV1451 PET imaging to assess target engagement of dasatinib and quercetin (D+Q) and impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker., Baseline to Week 48 | Washington University School of Medicine | The University of Texas Health Science Center at San Antonio|Wake Forest University Health Sciences | ALL | ADULT, OLDER_ADULT | PHASE2 | 48 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | IRB00067429 | 2021-12-22 | 2028-01 | 2029-01 | 2020-12-28 | 2025-03-28 | Wake Forest Health Sciences, Winston-Salem, North Carolina, 27157, United States|Fundación ACE Clinical Site, Barcelona, Spain|Hospital Clínic de Barcelona Site, Barcelona, Spain|Sant Pau Clinical Site, Barcelona, Spain|FISEVI Clinical Site, Sevilla, Spain | https://clinicaltrials.gov/study/NCT04685590 | ||||
| NCT05025956 | Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan | The purpose is to explore the possible benefit of administration of Fisetin, (a senolytic agent) to improve the benefit of Platelet-Rich Plasma and losartan for treatment of femoroacetabular impingement and labral tear. We believe that giving Fisetin, a senolytic agent, will improve the benefit of PRP by eliminating senescent cells and senescence-associated secretory phenotype (SASP), known to exist in PRP. The main objectives of this study are to determine if pre- and post-operative administration of a senolytic agent will improve the beneficial effects of PRP when used in conjunction with surgical treatment of FAI and/or labral tear, to determine whether pre- and postoperative administration of Fisetin is associated with adverse events, and to determine if pre- and post-operative administration of Fisetin leads to a decrease in systemic senescence, serum SASP, and fibrotic markers. Patients suffering from femoroacetabular impingement and labral tear, who are planning to undergo hip arthroscopy combined with standard of care intra-operative PRP injection and post-operative losartan administration will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC). | ACTIVE_NOT_RECRUITING | Femoroacetabular Impingement | DRUG: Fisetin|DRUG: Placebo | Incidence of Treatment-Emergent Adverse Events, Occurrence of adverse events, From date of study drug dosing until the end of the study, an average of 12 months | Patient Reported Outcomes Questionnaire-Modified Harris Hip Score (mHHS), Consists of 8 questions covering domains of pain, gait, and functional activities. Scored on a 100-point scale, with each answer receiving a specific amount of points. Higher score represents greater hip health., Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Patient Reported Outcomes Questionnaire- Hip Outcome Score: activities of daily living and sports subscales (HOS-ADL, HOS-SSS), Includes two subscales to calculate the total score:19 items in the HOS-ADL subscale and 9 items in the HOS-sports subscale., Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Scale from 0-96. Higher score represents worse hip health., Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Patient Reported Outcomes Questionnaire-Optum Short Form physical and mental component scores (SF-12 PCS and SF-12 MCS), Includes two subscales to calculate the total score. Higher score represents greater health. Scale standardized to a US Population mean of 50 and standard deviation of 10 points., Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Patient Reported Outcomes Questionnaire-Tegner Activity Scale, Scale from 0-10. Higher score represents greater activity level., Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Hip Pain, Scale from 1-10. Higher score represents greater hip pain., Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Patient Reported Outcomes Questionnaire-Patient satisfaction with surgical outcome, 1-10-point scale, Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op|Multi and singleplex immunoassays and flow cytometry senescence and SASP marker assessment of peripheral blood, Concentrations of secreted protein markers found in serum in pg/ml, Baseline, and 8-12 weeks post-op|Incidence of revision arthroscopy or other hip surgery required post initial arthroscopy, Incidence of revision surgery from day of initial surgery will be recorded, From day of initial surgery until the end of the study, an average of 12 months | Steadman Philippon Research Institute | United States Department of Defense | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 68 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 2020-058 | 2021-10-24 | 2024-10-31 | 2024-10-31 | 2021-08-30 | 2024-04-16 | The Steadman Clinic, Vail, Colorado, 81657, United States | https://clinicaltrials.gov/study/NCT05025956 | ||||||
| NCT05422885 | Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease | The purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of Dasatinib and Quercetin (D+Q) in older adults at risk of Alzheimer's disease (AD). The study will evaluate whether giving D+Q may improve cerebral blood flow regulation, mobility, and cognition in older adults, and thus may prevent progression to Alzheimer's disease. | STAMINA | COMPLETED | Aging | DRUG: Dasatinib|DRUG: Quercetin | Neurovascular Coupling, Change in cerebral blood flow during an N-back cognitive task using transcranial doppler ultrasound., Screening, 8, and 14 weeks|Executive Function, Assess change in executive cognitive function using TRAILS test, corrected for response time. Higher scores indicate worse executive functioning., Baseline, 8, and 14 weeks|Gait Speed, Assess change in gait speed. Performed without a distracting cognitive task., Baseline, 8, and 14 weeks|Montreal Cognitive Assessment (MoCA) Score, The Montreal Cognitive Assessment evaluates global cognition. Scores range from 0-30 points, with higher scores indicating better cognition, Baseline, 8, and 14 weeks | Physical Performance, Assessment of overall physical function using the short physical performance battery (SPPB) scored from 0-12, based on a composite of balance, strength, and walking speed. Higher scores indicate better mobility., Baseline, 8, and 14 weeks|Mobility, Test of mobility using timed up and go test, including standing from a chair, walking, and turning., Baseline, 8, and 14 weeks|Grip Strength, Measure of grip strength using a hand dynamometer., Baseline, 8, and 14 weeks|Gait Speed During Cognitive Task, Measure of gait speed during a cognitive task., Baseline, 8, and 14 weeks|P16 ink4a Expression in CD3 Positive Cells, Measure of P16 ink4a expression in senescent CD3 lymphocytes in the blood., Screening and 14 weeks|SASP Factors in Blood and Urine, Measure of the senescence-associated biomarkers IL-1alpha picogram/mL and IL-6 picogram/mL., Screening and 14 weeks|SASP Factors in Blood and Urine, Measure of the senescence-associated biomarkers MMP-9 nanograms/mL and MMP-12 nanograms/mL., Screening and 14 weeks | Lewis Lipsitz | ALL | OLDER_ADULT | PHASE1|PHASE2 | 15 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | Pro00053594 | 2022-05-20 | 2024-01-24 | 2024-01-24 | 2022-06-21 | 2025-03-25 | 2025-03-25 | Hebrew Senior Life, Boston, Massachusetts, 02131, United States | Study Protocol and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/85/NCT05422885/Prot_ICF_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/85/NCT05422885/SAP_001.pdf | https://clinicaltrials.gov/study/NCT05422885 | ||||
| NCT04771611 | COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications | The purpose of this study is to test whether Fisetin, a senolytic drug can assist in the reduction of complications in patients with COVID-19 infection. | COVFIS-HOME | COMPLETED | Covid19|Coronavirus Infection | DRUG: Fisetin|DRUG: Placebo | World Health Organization (WHO) Ordinal Scale Score, The number of subjects who scored as No limitations (Score 0-1) and Ambulatory, limitations (score 2-8) on the WHO Ordinal Scale score. The 9 points of the WHO ordinal clinical severity scale are as follows: 0: no clinical or virological evidence of infection; 1: ambulatory, no activity limitation; 2: ambulatory, activity limitation; 3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen mask or nasal prongs; 5: hospitalized, noninvasive mechanical ventilation (NIMV) or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation (ECMO); 8: death. Total scores range from 0-8. Lower scales indicate less limitations, higher scores indicate more limitations., 60 days | Serious Adverse Events, The number of serious adverse events reported, 60 days | James L. Kirkland, MD, PhD | ALL | ADULT, OLDER_ADULT | PHASE2 | 55 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 20-009705 | 2021-07-14 | 2022-09-27 | 2022-09-27 | 2021-02-25 | 2023-08-01 | 2023-08-01 | Mayo Clinic, Rochester, Minnesota, 55905, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/11/NCT04771611/Prot_SAP_000.pdf | https://clinicaltrials.gov/study/NCT04771611 | ||||
| NCT04235309 | Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2 | The purpose of this study is to examine underlying physical resilience (the ability to bounce back) in response to a specific stressor (total knee replacement). | PRIME-Knee | COMPLETED | Resilience|Aging | Change in musculoskeletal resiliency following orthopedic surgery as measured by physical activity (step counts), As measured by a Garmin device worn by participants, Baseline, 1 week, 1 month, 2 months, 4 months and 6 months|Change in musculoskeletal resiliency following orthopedic surgery as measured by Lower Extremity Physical Activities of Daily Living (LE PADLs), Scores are measured from 0 to 45. Higher scores are associated with more limited LE PADLs., Baseline, 6 months|Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Intensity, Scores are measured from 3 to 15. Higher scores are associated with more intense pain., Baseline, 1 week, 1 month, 2 months, 4 months and 6 months|Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Interference, Scores are measured from 6 to 30. Higher scores are associated with increased pain interference., Baseline, 1 week, 1 month, 2 months, 4 months and 6 months|Change in cognitive resiliency following orthopedic surgery as measured by 3D-CAM., Scored as positive or negative. Positive indicates the presence of delirium., Baseline, 1 week|Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for patient., Scores range from 20 - 100. Higher scores are associated with increased cognitive decline., Baseline, 1 month, 2 months, 4 months, 6 months|Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for informant about patient., Scores range from 20 - 100. Higher scores are associated with increased cognitive decline., Baseline, 1 month, 2 months, 4 months, 6 months|Change in association between in vitro immune resiliency and resilient outcomes following elective orthopedic surgery., Whole blood samples containing PBMCs collected before/after surgery will be challenged with LPS and influenza vaccine to assess the cellular immune response using previously identified biomarkers of resiliency and RNA-seq analysis to identify novel biomarkers and molecular signatures., Baseline, Post-operative Day 1 | Change in dual task gait speed, Score of combined walking and verbal fluency test, Baseline, 6 months|Change in tissue oxygenation index (TOI), Measured using fNIRs (functional near infrared spectroscopy), Baseline, 6 months|Intraoperative electrocardiography (ECG) RR variability, Measured as intra-operative ECG RR intervals collected from the heart monitor, Surgery up to three hours | Duke University | National Institute on Aging (NIA) | ALL | ADULT, OLDER_ADULT | 297 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Pro00103483|4UH3AG056925-03 | 2020-02-27 | 2023-10-30 | 2023-10-30 | 2020-01-21 | 2024-03-25 | Duke Regional Hospital, Durham, North Carolina, 27704, United States|Duke University Hospital, Durham, North Carolina, 27710, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States | https://clinicaltrials.gov/study/NCT04235309 | |||||||
| NCT04476953 | COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation | The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction. | ACTIVE_NOT_RECRUITING | Covid19 | DRUG: Placebo|DRUG: Fisetin | Serious Adverse Events, Number of participants to experience serious adverse events and hypersensitivity reactions., 6 months|Change in oxygenation status, change in oxygenation levels as measured by S/F ratio (SPO2/FiO2), baseline, Day 3, 7, 10, 14, 17 and 30; Months 3 and 6 | CoV Severity Category, Number of participants to progress to severe or critical classification CoV, 6 months | Mayo Clinic | ALL | ADULT, OLDER_ADULT | PHASE2 | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 20-003936 | 2020-08-03 | 2025-09 | 2025-09 | 2020-07-20 | 2025-03-25 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT04476953 | |||||||
| NCT05593588 | Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency | The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo. | ENROLLING_BY_INVITATION | Common Variable Immunodeficiency|Interstitial Lung Disease Due to Systemic Disease | DRUG: Fisetin|DRUG: Placebo | Change in immunophenotyping of peripheral T lymphocytes, Measured by percentage of activated CD4+25+ T cells, Baseline, 6 months | Change in Forced Vital Capacity (FVC), Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L), Baseline, 6 months|Change in radiologic imaging in subjects, Number of subjects to have a 10% improvement with the CT scoring system. Radiologist will score the CT scans at each time point and changes in score at each time point will be noted., Baseline, 3 months, 6 months|Use of MRI imaging for assessment of GLILD, Number of MRI images that were used to assess for GLILD compared to High-resolution Computed Tomography (HRCT) use, 6 months|Infectious complications, Number of subjects to experience infectious complications, 6 months|Adverse Events, Number of adverse events reported, 6 months|Change in quality of life, Measured using the RAND 36-Short Form Survey Instrument (SF-36). The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability, Baseline, 6 months|Change in 6 minute walk test, Number of subjects to have a 10% improvement in 6 minute walk test. The 6 minute walk test measures the distance a person is able to walk in 6 minutes., Baseline, 6 months | Avni Joshi | ALL | ADULT, OLDER_ADULT | PHASE2 | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 21-003119 | 2023-04-12 | 2025-12 | 2026-12 | 2022-10-25 | 2024-04-26 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | https://clinicaltrials.gov/study/NCT05593588 | |||||||
| NCT04176133 | Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination | Researchers are evaluating the safety and effectiveness of a single administration of entolimod when administered at the same time as the influenza vaccine (flu vaccine). | COMPLETED | Healthy | DRUG: Entolimod|DRUG: Placebo|DRUG: Influenza vaccine | Change in Anti- A/H1N1 Antibody Titer, Change of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month., Baseline, 1 month|Change in Anti-A/H3N2 Antibody Titer, Change of the anti-A/H3N2 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month., Baseline, 1 month|Change in Anti-B Antibody Titer, Change of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.., Baseline, 1 month|Adverse Events, The number of adverse events (AEs) related to dose limiting toxicities (DLTs); laboratory abnormalities; oxygen saturation and vital sign changes, and adverse electrocardiogram (ECG) findings for 1 year, 1 year | Time of Onset for Upper-respiratory Infections, Subject self-reporting of the number of days to develop an upper-respiratory infection, 1 year|Upper Respiratory Infections, The total number of subjects to self-report an upper-respiratory infection, 1 year|Change in Frailty, Change in self-reported 5 items frail scale. Frail scale scores range from 0-5, 1 point for each component, 0 = best 5 = worst (robust=0 points; pre-frail=0-1 points; frail 3-5 points), baseline, 2 months|Change in 6-minute Walk Test, Distance a subject is able to walk over 6 minutes over a hard flat surface, baseline, 2 months|Change in Grip Strength, Measured by a grip dynamometer as reported in units of pounds., baseline, 2 months|Change in Body Mass Index (BMI), Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions), baseline, 2 months | Robert J. Pignolo | Genome Protection, Inc. | ALL | OLDER_ADULT | PHASE2 | 61 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION | 19-004847 | 2019-10-30 | 2022-03-30 | 2022-03-30 | 2019-11-25 | 2023-06-22 | 2023-06-22 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT04176133/Prot_SAP_000.pdf | https://clinicaltrials.gov/study/NCT04176133 |
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