Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
NCT ID: NCT07000734
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-07-28
2026-05-31
Brief Summary
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Detailed Description
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The intervention will last for approximately 3 months, with testing of motor, cognitive, and immune outcomes before and after the intervention.
The intervention consist of three components:
1. Fortify Healthy Behaviors: behavioral lifestyle management that combines an exercise program, healthy eating behaviors and optimizing sleep quality;
2. Optimize Medical Therapies: reviewing the participants cardiovascular risk factors, smoking cessation when indicated, treatment with the senolytic medication dasatinib combined with the antioxidant quercetin , and dietary supplements relevant for brain, bone and immune system functioning; and
3. Enhance Cognitive Function: vortioxetine (an antidepressant shown to have pro-cognitive properties), in combination with digital cognitive training to improve fluid cognition and memory, and deprescribing of drugs with CNS toxicity (i.e. those that cause cognitive difficulties).
The outcome assessments will be measured both pre- and post-intervention and up to three times at each time point. These assessments will look at biomarkers related to aging. Assessments will include strength and endurance tests, validated neuropsychological tests, and a blood drawn to look at immune function.
An MRI scan will also be offered to participants who are able to undergo the scan to look at brain health and aging, both pre- and post-intervention.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine
Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
Risk managment
Behavioral lifestyle changes including an exercise program, healthy eating recommendations, reviewing medical management for cardiometabolic risk conditions, deprescribing review for brain toxic meds, online cognitive training, as well as recommendations to improve sleep quality, or smoking cessation as needed
Dasatinib
dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
Quercetin (dietary supplement)
e intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
Vortioxetine
Participants will be prescribed vortioxetine to take daily, in combination with online cognitive training
Interventions
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Risk managment
Behavioral lifestyle changes including an exercise program, healthy eating recommendations, reviewing medical management for cardiometabolic risk conditions, deprescribing review for brain toxic meds, online cognitive training, as well as recommendations to improve sleep quality, or smoking cessation as needed
Dasatinib
dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
Quercetin (dietary supplement)
e intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
Vortioxetine
Participants will be prescribed vortioxetine to take daily, in combination with online cognitive training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to come to the research center for testing and intervention visits.
* Sedentary (no moderate exercise and no more than 15-minutes per day of light exercise (confirmed via interview with participants)).
* BMI≥27 or Body Roundness index ≥6
* Able to provide informed consent.
Exclusion Criteria
* Medical conditions that suggest shortened lifespan (such as metastatic cancer), severe/uncontrolled psychiatric disorders or conditions that would prohibit safe participation.
* Unable to perform study assessments.
* Alcohol or substance abuse within 6 months per self-report or medical records.
* Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity.
* Any drug that interacts pharmacokinetically, or is contraindicated with study interventions (examples would include high-dose SSRI that should not be combined with vortioxetine)
* PI has discretion to exclude potential participants eg if their health status appears either too good or too poor to be amenable to intervention
50 Years
70 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Eric Lenze, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202503023
Identifier Type: -
Identifier Source: org_study_id