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)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
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⁃ 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

Locations
United States
Arizona
Arizona State University
RECRUITING
Phoenix
Contact Information
Primary
Kristi Spieleder, MS
kspieled@asu.edu
480-884-2765
Time Frame
Start Date: 2023-06-22
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 216
Treatments
Experimental: Moderate Intensity Continuous Training (MICT)
Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months
Sham_comparator: Chair-based Stretch
Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months
Active_comparator: High-Intensity Interval Training (HIIT)
MICT for 3 months, and then cycling on recumbent stationary cycle at alternate high and moderate intensity for 40 minutes, 3 times per week for 3 months.
Active_comparator: Combined Aerobic Resistance Exercise (CARE)
MICT for 3 months, and then cycling on recumbent stationary cycle at moderate intensity for 30 minutes, followed by 20-minute strength-building exercise, 3 times per week for 3 months.
Sponsors
Collaborators: Banner Alzheimer's Institute
Leads: Arizona State University

This content was sourced from clinicaltrials.gov