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

Purpose

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
  • Sedentary Behaviors
  • Immune Senescence
  • Motor Function

Eligibility

Eligible Ages
Between 50 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine 		Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
  • Behavioral: Risk managment
    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
  • Drug: Dasatinib
    dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
    Other names:
    • sprycel
    • sophoretin
  • Dietary Supplement: Quercetin (dietary supplement)
    e intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial
    Other names:
    • quercetine
    • Vitamin P
  • Drug: Vortioxetine
    Participants will be prescribed vortioxetine to take daily, in combination with online cognitive training
    Other names:
    • Trintellix
    • Brintellix

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Aris Perez
314-747-8906
arisperez@wustl.edu

More Details

NCT ID
NCT07000734
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Aris Perez
314-747-8906
arisperez@wustl.edu

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.