N/A
N=119
Exercise for Brain Health in the Fight Against Alzheimer's Disease
Healthy Cognition
Bottom Line
View on ClinicalTrials.gov: NCT03727360 ↗Enrolled (actual)
119
Serious AEs
3.4%
Results posted
May 2026
Primary outcome: Primary: Rey Auditory Verbal Learning Test Sum of Trials 1-5 — 49.7; 47.6; 51.6; 49.4 Sum of words recalled Trials 1 to 5
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Training (Other); Flexibility Control (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Maryland, College Park
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rey Auditory Verbal Learning Test Sum of Trials 1-5 |
49.7; 47.6; 51.6; 49.4 | — |
| PRIMARY Famous Name Discrimination fMRI Activation |
5.20; 5.13; 4.25; 3.19 | — |
| SECONDARY Peak Rate of Oxygen Consumption (VO2peak) |
1.34; 1.33; 1.31; 1.35 | — |
| SECONDARY 6 Minute Walk Test |
1758.3; 1712.8; 1796.7; 1734.3 | — |
Summary
The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.
Eligibility Criteria
Inclusion Criteria
- 60 to 80 years old
- Fluent in English
- Willingness to make the time commitment to participate in the project, including randomization to treatments
- Physically inactive (physical activity not more than 2 days per week for the past 6 months)
- Physician consent to undergo an exercise stress test and engage in moderate intensity exercise
- Determined to be safe for MRI
Exclusion Criteria
- Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease
- Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease
- Untreated severe major depression
- Substance abuse or dependence
- Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants
- Use of acetylcholinesterase inhibitors (e.g., Aricept)
- Unstable or severe cardiovascular disease or asthmatic condition
- History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke
- Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment
Data sourced from ClinicalTrials.gov (NCT03727360). 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.