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

NCT07000734 | Completed Phase 2 FDA Drug

• 1 other identifier: 202503023
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Cognitive Decline; Older Adults; Cardiovascular; Motor Function; Sedentary Behaviors; Immune Senescence

Outcome Measures

Primary Outcomes (1)

• Number of participants who completed the outcome measure assessments and intervention

  Reviewing feasibility outcomes including recruitment, retention, participant adherence, interventionist fidelity to behavioral treament protocols and collection of outcome measures.

  5 months

Other Outcomes (3)

• Motor function

  5 months

• Cognitive Function

  5 months

• Immune Function

  5 months

Study Arms (1)

Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine

EXPERIMENTAL

Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies

Behavioral: Risk managment; Drug: Dasatinib; Dietary Supplement: Quercetin (dietary supplement); Drug: Vortioxetine

Interventions

Risk managment BEHAVIORAL

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

Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine

Dasatinib DRUG

dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial

Also known as: sprycel, sophoretin

Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine

Quercetin (dietary supplement) DIETARY_SUPPLEMENT

e intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial

Also known as: quercetine, Vitamin P

Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine

Vortioxetine DRUG

Participants will be prescribed vortioxetine to take daily, in combination with online cognitive training

Also known as: Trintellix, Brintellix

Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sedentary Behavior

Interventions

Dasatinib; Quercetin; Dietary Supplements; Vortioxetine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Piperazines

Study Officials

• Eric Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 3, 2025
• Study Start: July 28, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)