NCT05877196 · RECRUITING
A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
This trial is testing four different exercise programs, ranging from gentle stretching to high-intensity interval training, in older adults aged 65 and up who already have mild cognitive impairment or early Alzheimer's disease. Researchers want to find out which type of exercise best improves cardiovascular fitness and reduces brain changes visible on MRI. This is a Phase NA adaptive trial, meaning it is designed to compare approaches and find what works best, not a standard drug approval study.
Eligibility 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-04-22