Lifestyle Changes and Medications for Aging Adults

(FOES Trial)

Overseen By Angela Stevens

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: High-dose SSRIs

Disqualifiers: Dementia, Parkinson's, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost movement, thinking, and immune health in aging adults through lifestyle changes, risk management, and medications such as dasatinib, quercetin (a dietary supplement), and vortioxetine (an antidepressant). The trial seeks participants living in Illinois or Missouri, aged 50 to 70, who do not exercise regularly. Participants must be able to visit the research center in St. Louis. This study may suit individuals with a higher body mass index (BMI) or body roundness index who can provide informed consent. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial may require you to stop certain medications if they interact with the study treatments. It's best to discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of dasatinib and quercetin is safe for older adults. Studies indicate it is well-tolerated, even for those who walk slowly or have mild memory problems. No major safety issues have been reported, which is encouraging.

For vortioxetine, one study found it generally safe for older adults as well. Some participants experienced nausea and headaches, but these were the most common side effects. Overall, the treatment seems manageable for most people.

Both treatments in this trial have demonstrated safety in previous studies, which is reassuring for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment because it combines lifestyle management with medications like dasatinib, quercetin, and vortioxetine, which offer a new approach to managing health risks in aging adults. Unlike standard treatments that might focus solely on one aspect, such as medication or lifestyle changes separately, this intervention is a multicomponent and personalized strategy. Dasatinib and quercetin are particularly interesting because they have potential senolytic properties, meaning they might help clear out damaged cells that contribute to aging. Meanwhile, vortioxetine is known for its antidepressant effects, which could support mental health in older adults. This holistic approach aims to tackle aging-related challenges more comprehensively than current options.

What evidence suggests that this trial's treatments could be effective for improving motor, cognitive, and immune functions in aging adults?

Research has shown that combining dasatinib and quercetin, which participants in this trial may receive, can improve physical and mental abilities. These compounds might reduce inflammation and slow aging. In older adults at risk for Alzheimer's, this combination was well-tolerated and showed potential benefits for the brain. Vortioxetine, an antidepressant included in the treatment arm of this trial, enhanced thinking skills in previous studies. Together, these treatments aim to boost brain function and support healthy aging. ^{4 6 7 8 9}

Who Is on the Research Team?

Eric Lenze, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for Illinois or Missouri residents aged 50-70 who are sedentary, with a BMI≥27 or Body Roundness index ≥6. They must be able to visit the St. Louis research center and provide informed consent. Excluded are those with good/poor health as judged by the PI, dementia, severe psychiatric disorders, substance abuse within 6 months, life-shortening medical conditions, or taking drugs that interact with study treatments.

Inclusion Criteria

Participants must be residents of Illinois or Missouri and able to come to St. Louis offices in person

I am between 50 and 70 years old.

Sedentary (no moderate exercise and no more than 15-minutes per day of light exercise, confirmed via interview with participants)

Exclusion Criteria

PI has discretion to exclude potential participants if their health status appears either too good or too poor to be amenable to intervention

Dementia or other clinical neurodegenerative illness per self-report or medical records

Medical conditions that suggest shortened lifespan, severe/uncontrolled psychiatric disorders, or conditions that would prohibit safe participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a multi-component intervention including lifestyle management, medical therapies, and cognitive enhancement

3 months

Multiple visits for assessments and interventions

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 months

Assessments conducted pre- and post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Dasatinib
• Quercetin (dietary supplement)
• Risk management
• Vortioxetine

Trial Overview

The study tests lifestyle changes and risk management alongside medications like Dasatinib and Vortioxetine plus Quercetin supplement to enhance motor skills, cognitive function, and immune health in older adults leading a sedentary lifestyle.

How Is the Trial Designed?

Group I: Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine Experimental Treatment 4 Interventions

Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07000734?intr=vortioxetine&aggFilters=status:not%20rec%20act%20enr&rank=8

Fortifying Healthy Behaviors, Optimizing Medical Therapies ...

Enhance Cognitive Function: vortioxetine (an antidepressant shown to have pro-cognitive properties), in combination with digital cognitive training to improve ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37261678/

Long-term dasatinib plus quercetin effects on aging outcomes ...

Long-term dasatinib plus quercetin effects on aging outcomes and inflammation in nonhuman primates: implications for senolytic clinical trial ...

3.

fightaging.org

fightaging.org/archives/2025/03/results-from-a-small-trial-of-dasatinib-and-quercetin-in-patients-with-mild-cognitive-impairment/

Results from a Small Trial of Dasatinib and Quercetin in ...

Studies have demonstrated that co-administration of Dasatinib and Quercetin improved aspects of both physical and cognitive function in mice.

4.

marcusinstituteforaging.org

marcusinstituteforaging.org/news/pilot-study-suggests-treatment-may-improve-cognition-older-adults-risk-alzheimers-disease

Pilot Study Suggests Treatment May Improve Cognition in ...

“Our findings suggest that senolytic treatment with dasatinib and quercetin is well-tolerated in older adults at risk for Alzheimer's disease ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04946383

Safety and Effectivness of Quercetin & Dasatinib on ...

There is evidence that Quercetin and Dasatinib slows cell proliferation and decelerates aging and the risk of age-related diseases. The aim of this pilot study ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05422885?intr=Dasatinib%20%2B%20Quercetin&rank=2

Safety and Feasibility of Dasatinib and Quercetin in Adults ...

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 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11907475/

A pilot study of senolytics to improve cognition and mobility in ...

Our study findings suggest that administering Dasatinib and Quercetin to older adults with slow walking speed and MCI appears feasible and safe. Furthermore, ...

8.

nmn.com

nmn.com/news/new-harvard-study-anti-aging-senolytics-are-safe-for-seniors-with-memory-loss

New Harvard-Mayo-Cedars-Sinai Joint Study Confirms ...

The senolytics dasatinib and quercetin (DQ) are safe and tolerable for older adults with cognitive and motor impairments, but do they improve ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1064748113006027

The Safety and Tolerability Profile of Vortioxetine in ...

The most common AEs (≥5%) in the elderly population group treated with vortioxetine or placebo were nausea (22.4% vs. 7.5%), headache (9.8% vs. 16.0 ...