Clinical trial NCT07000734: Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
Official title: Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Aging
Cognitive Decline
Older Adults
Cardiovascular
Sedentary Behaviors
Immune Senescence
Motor Function
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Number of participants who completed the outcome measure assessments and intervention
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
measure: Motor function
timeFrame: 5 months
measure: Cognitive Function
timeFrame: 5 months
measure: Immune Function
timeFrame: 5 months
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References: