Clinical trial Recruiting at 1 site Interventional Ages 65 and up

Aerobic exercise program for older adults with mild cognitive impairment

Official title: Precision Medicine in Alzheimer's Disease: A SMART Trial of Adaptive Exercises and Their Mechanisms of Action Using AT(N) Biomarkers to Optimize Aerobic-Fitness Responses (The FIT-AD SMART Trial)

Run by Arizona State University · NCT05877196 · Data updated 2026-11-12

This study is testing if a 6-month aerobic exercise program can help older adults with mild cognitive impairment or early Alzheimer's improve their brain health and fitness.

Quick facts

Study typeInterventional
Ages65 Years and up
SexAll
Enrollment216 (estimated)
SponsorArizona State University
Academic / other
Locations1 site (Phoenix, Arizona)
StatusRecruiting
StartedJune 22, 2023
Main results expectedApril 1, 2027
Study endsJune 30, 2028
Registry record updatedMay 5, 2026
Trial IDNCT05877196 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are community-dwelling adults aged 65 and older with a clinical diagnosis of mild cognitive impairment or early Alzheimer's disease.

Probably not a fit

Patients with significant cardiac issues or those currently enrolled in other cognitive improvement interventions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of a 6-month aerobic exercise program on older adults aged 65 and above who have mild cognitive impairment or early Alzheimer's disease. Participants will engage in various exercise interventions, including moderate intensity continuous training and high-intensity interval training, while undergoing cognitive assessments and MRI scans to monitor changes in brain health and fitness levels. The study seeks to identify the most effective exercise regimen for improving aerobic fitness and cognitive outcomes, as well as to explore the underlying mechanisms of exercise on memory function. Monthly follow-ups will provide additional support and health discussions for participants throughout the trial.

Why it matters

Potential benefit: If successful, this program could enhance aerobic fitness and cognitive function in older adults, potentially slowing the progression of Alzheimer's disease.

How similar studies have gone: Previous studies have shown mixed results regarding the effects of aerobic exercise on cognitive function in dementia, indicating that while some approaches have been beneficial, this specific adaptive exercise methodology is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participants:

* Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria.
* Community-dwelling, e.g., homes and assisted living
* Age 65 years and older
* Medical clearance from PCP or cardiovascular provider
* Have a qualified study partner
* Agree to the blood draws
* Verified MRI safety

Study Partner:

* Age 18 or older
* Contact with participant ≥ 2 times per week for ≥ 6 months
* Know the participant's memory status and ability to perform activities of daily living
* Consent to participant

Exclusion Criteria:

Participants

* Resting HR ≤ 50 or ≥ 100 beats/min after 5-minutes of quiet resting
* American College of Sports Medicine contraindications to exercise
* New, unevaluated symptoms or diseases a healthcare provider has not evaluated
* Abnormal cardiac condition uncovered during VO2peak testing
* Enrollment in another intervention that aims at improving cognition
* Moderate to strenuous exercise ≥150 minutes a week in the previous 6 months
* ≥ 2 anti-depression medications, or poorly managed or unstable depression
* Poorly managed or unstable anxiety

Study partners:

* none

Where it's running

  • Arizona State University
    Phoenix, Arizona, United States
    Recruiting

Study contacts

  • Principal investigator: Fang Yu, PhD — Arizona State University
  • Study coordinator: Kristi Spieleder, MS
  • Email: kspieled@asu.edu
  • Phone: 480-884-2765

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.