NCT05877196Recruiting
A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
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)
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
The goal of this clinical trial is to test 6 months of aerobic exercise in older adults who are 65 years or older and have mild cognitive impairment (MCI) or probable/possible mild Alzheimer's Disease. The main questions it aims to answer are: * test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes; * identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and * examines the mechanisms of aerobic exercise's action on memory in older adults with early AD. Participants will receive 6 months of supervised exercise, undergo cognitive data collection and exercise testing 5 times over a year span, have an MRI brain scan 3 times over a one-year span, and have monthly follow-up discussions on health and wellness.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 3 Apr 2023
- Start date
- 22 Jun 2023
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Arizona State University
- Diseases
- Alzheimer disease
- NCT number
- NCT05877196
What you commit to
- Study type: Interventional
- Planned participants: 216
- From 22 Jun 2023 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Moderate to strenuous exercise ≥150 minutes a week in the previous 6 months
- ≥ 2 anti-depression medications, or poorly managed or unstable depression
Other illness
- New, unevaluated symptoms or diseases a healthcare provider has not evaluated
- Abnormal cardiac condition uncovered during VO2peak testing
Other
- Participants
- Resting HR ≤ 50 or ≥ 100 beats/min after 5-minutes of quiet resting
- American College of Sports Medicine contraindications to exercise
- Enrollment in another intervention that aims at improving cognition
- Poorly managed or unstable anxiety
- Study partners:
- none
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arizona State University Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.