AgingPhase 2FOESNCT07000734
Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
A Phase 2 study testing Risk managment, Dasatinib and Quercetin (dietary supplement) in people with Aging and Cognitive Decline, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Aging, Cognitive Decline, Older Adults
- What is being tested?
- Risk managment, Dasatinib and Quercetin (dietary supplement)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 30 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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:
- Fortify Healthy Behaviors: behavioral lifestyle management that combines an exercise program, healthy eating behaviors and optimizing sleep quality;
- 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
- 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
- Aging, Cognitive Decline, Older Adults, Cardiovascular, Sedentary Behaviors, Immune Senescence
- Being tested
- Risk managment, Dasatinib, Quercetin (dietary supplement), Vortioxetine
- Medical subject headings
- Cognitive Dysfunction, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk managmentBehavioural
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
DasatinibDrug
Also called sprycel, sophoretin
dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
Quercetin (dietary supplement)Dietary supplement
Also called quercetine, Vitamin P
e intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
VortioxetineDrug
Also called Trintellix, Brintellix
Participants will be prescribed vortioxetine to take daily, in combination with online cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine | Experimental | Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies Receives: Behavioral: Risk managment; Drug: Dasatinib; Dietary Supplement: Quercetin (dietary supplement); Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start28 Jul 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Lenze, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000734
- Sponsor's protocol ID
- 202503023
- Acronym
- FOES
- Status last verified
- Aug 2026
- First submitted
- 19 May 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact PI
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
- ClinicalTrials.gov ID
- NCT07000734
- Acronym / sponsor ID
- FOES / 202503023
- Conditions
- Aging, Cognitive Decline, Older Adults, Cardiovascular, Sedentary Behaviors, Immune Senescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Fortify Healthy Behaviors: behavioral lifestyle management that combines an exercise program, healthy eating behaviors and optimizing sleep quality;
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine | Experimental | Behavioral: Risk managment, Drug: Dasatinib, Dietary Supplement: Quercetin (dietary supplement), Drug: VortioxetineOpen label multicomponent, personalized intervention incorporating behavioral and medicinal therapies |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk managmentBehavioral 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 | Behavioural | Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine |
| DasatinibAlso: sprycel, sophoretindasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial | Drug | Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine |
| Quercetin (dietary supplement)Also: quercetine, Vitamin Pe intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial | Dietary supplement | Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine |
| VortioxetineAlso: Trintellix, BrintellixParticipants will be prescribed vortioxetine to take daily, in combination with online cognitive training | Drug | Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine |
Primary outcome
Number of participants who completed the outcome measure assessments and intervention
Time frame: 5 months
Reviewing feasibility outcomes including recruitment, retention, participant adherence, interventionist fidelity to behavioral treament protocols and collection of outcome measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Contact PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lenze, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Risk managment, Dasatinib and Quercetin (dietary supplement) in people with Aging and Cognitive Decline, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who completed the outcome measure assessments and intervention (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.