N/A
N=117
Alzheimer's Prevention Through Exercise
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02000583 ↗Enrolled (actual)
117
Serious AEs
10.3%
Results posted
Jul 2020
Primary outcome: Primary: Amyloid Burden — 1.20; 1.22; 1.21; 1.22 Standard Uptake Value Ratio (SUVR)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic Exercise (Other); Standard of Care (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amyloid Burden |
1.20; 1.22; 1.21; 1.22 | — |
| SECONDARY Whole Brain Volume |
1068.7; 1061.7; 1063.4; 1059.1 | — |
| SECONDARY Executive Function |
0.029; -0.042; 0.017; -0.035; .018; -0.037 | — |
Summary
The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.
Eligibility Criteria
Inclusion Criteria
- Clinical Dementia Rating 0 (nondemented)
- Age 65 or older
- Florbetapir PET evidence of cerebral amyloidosis
- Sedentary or underactive by the Telephone Assessment of Physical Activity
- Stable doses of medications for 30 days.
- Clinician judgment regarding subject's health status and likelihood to successfully complete the 1-year exercise intervention
Exclusion Criteria
- Clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to standard criteria or significant psychiatric symptoms that could impair the completion of the study
- Clinically-significant systemic illness that may affect safety or completion of the study
- History of clinically-evident stroke
- Clinically-significant infection within the last 30 days
- Active cardiac condition (e.g. angina, myocardial infarction, atrial fibrillation) or pulmonary condition in the past 2 years that, in the investigator's opinion, could pose a safety risk to the participant-unless cleared for exercise by the participant's primary care physician or cardiologist.
- Uncontrolled hypertension within the last 6 months
- History of cancer in the last 5 years (except non-metastatic basal or squamous cell carcinoma)
- History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
- Insulin-dependent diabetes mellitus
- Significant pain or musculoskeletal disorder prohibiting participation in an exercise program
- Unwillingness to undergo or contraindication to brain MRI scan.
- History within the last 5 years of primary or recurrent malignant disease with the exception of resected localized cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma, or prostate cancer.
Data sourced from ClinicalTrials.gov (NCT02000583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.