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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 65 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "The purpose of this Phase II, mechanistic Sequential, Multiple Assignment, Randomized Trial (SMART) is to test the effects of 6-month aerobic exercise on aerobic fitness and MRI and plasma biomarkers in community-dwelling older adults with early Alzheimer's disease (AD)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests 6 months of supervised aerobic exercise, which makes your heart and breathing work harder. It is for adults age 65 or older with mild memory and thinking problems or possible or likely mild Alzheimer's disease. Researchers want to find which exercise works best for fitness and how it affects memory and brain changes.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 65 or older.
- Have a diagnosis of mild cognitive impairment (mild memory and thinking problems) or possible or likely mild Alzheimer's disease.
- Live in the community, such as at home or in assisted living.
- Have approval to exercise from your primary care provider or heart care provider.
- Agree to blood draws and be checked to make sure an MRI brain scan is safe for you.
- Have a study partner who is age 18 or older.
- Your study partner must have contact with you at least twice a week for at least 6 months.
- Your study partner must know about your memory and daily living skills and give consent for your participation.
Who can't join
- Have a heart rate of 50 beats per minute or less, or 100 or more, after resting quietly for 5 minutes.
- Have a condition that makes exercise unsafe under American College of Sports Medicine guidelines.
- Have new symptoms or illnesses that a health care provider has not checked.
- Have a heart problem found during the study's fitness test.
- Be in another treatment study or program meant to improve memory and thinking.
- Have done at least 150 minutes of moderate to hard exercise each week during the past 6 months.
- Take 2 or more medicines for depression, or have depression that is not well controlled or is unstable.
- Have anxiety that is not well controlled or is unstable.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
AZ
- Arizona State University · Phoenix, AZ 85004Kristi Spieleder, MS · Study contact · 480-884-2765 · kspieled@asu.eduFang Yu, PhD · Principal investigatorDavid Coon, PhD · Sub-investigatorRodney Joseph, PhD · Sub-investigatorMore trials in Phoenix