Alzheimer Disease Clinical Trial
— SMARTOfficial title:
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)
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 | Recruiting |
Enrollment | 216 |
Est. completion date | June 30, 2028 |
Est. primary completion date | April 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Arizona State University | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | Banner Alzheimer's Institute |
United States,
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* Note: There are 52 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dementia severity | Montreal cognitive Assessment: score 0-30; higher scores reflect less impairment | measured at 0, 3, 6, 9, & 12 months | |
Other | Executive function | Trail Making Test: number of seconds required to complete the task; therefore, higher scores reveal greater impairment | measured at 0, 3, 6, 9, & 12 months | |
Other | Visuospatial ability | Benson Complex Figure: score 0-17; higher scores reflect better visuospatial abilities. | measured at 0, 3, 6, 9, & 12 months | |
Other | Language preservation | Multilingual naming test: count the number of items correctly named; higher counts reflect better language preservation | measured at 0, 3, 6, 9, & 12 months | |
Other | Fall risk | Timed up and Go: 3-meter course timed; time recorded in seconds; less time reflects lower fall risk | measured at 0, 3, 6, 9, & 12 months | |
Other | Social interaction | Engagement and Independence in Dementia Questionnaire: Scale - not true at all = 0, rarely true = 1, sometimes true = 2, often true = 3, true nearly all of the time = 4; higher ratings reflect more social interaction | measured at 0, 3, 6, 9, & 12 months | |
Other | Anxiety | Generalized Anxiety Disorder - 7: 0-21; lower scores reflect less anxiety | measured at 0, 3, 6, 9, & 12 months | |
Other | Depression | Geriatric Depression Scale: Score 1-15, lowers scores reflect less depression | measured at 0, 3, 6, 9, & 12 months | |
Primary | Peak oxygen consumption | VO2peak will be assessed from the symptom-limited peak cycle-ergometer test | measured at 0 and 6 months | |
Primary | White Matter Hyperintensity volume | WMH will be assessed from MRI. | measured at 0 and 6 months | |
Secondary | Memory | Wechsler Memory Scale - Revised; Logical Memory; score 0-50; higher scores indicate less impairment | measured at 0, 6, and 12 months | |
Secondary | Physical function | Short Physical Performance Battery: score 0-12; lower scores indicate poorer physical function | measured at 0, 3, 6, 9, & 12 months | |
Secondary | Behavioral and psychiatric symptoms of dementia (BPSD) | Neuropsychiatric Inventory Questionnaire; symptoms present, if yes, then severity and caregiver distress are reported. | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Caregiver burden | 4-item Zarit Burden Interview: score 0-16; higher scores reflect greater burden | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Quality of Life (QoL) | Quality of Life - AD: score 0-52; higher scores reflect greater life satisfaction | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Blood amyloid-beta 42 and 40 | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Blood phosphorylated tau 181 | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Blood total tau, neurofilament light chain | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months |
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