Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study

Phase 2

Not yet recruiting

• Conditions: Aging; Cognitive Decline; Older Adults; Cardiovascular; Sedentary Behaviors; Immune Senescence; Motor Function
• Interventions: Behavioral: Risk managment; Drug: Dasatinib; Dietary Supplement: Quercetin (dietary supplement); Drug: Vortioxetine

• Registration Number: NCT07000734
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.

Detailed Description

The goal in this pilot open-label study is to conduct a feasibility test of a multi-component, personalized intervention designed to improve the aging human healthspan. The trial will recruit at least 20 adults aged 50-70, both male and female. The total time of study participation is up to 5 months.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study Start: 2025-06
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ages 50-70
• 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

• Dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease unless minor eg one lacunar infarct with minimal/no impairment) per self-report or medical records.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine	Vortioxetine	Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine	Risk managment	Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine	Dasatinib	Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine	Quercetin (dietary supplement)	Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies

Primary Outcome Measures

Name	Time	Method
Number of participants who completed the outcome measure assessments and intervention	5 months	Reviewing feasibility outcomes including recruitment, retention, participant adherence, interventionist fidelity to behavioral treament protocols and collection of outcome measures.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States