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New treatment option for Mild Cognitive Impairment
Official title A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
ClinicalTrials.gov ID: NCT05877196
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.