Exercise for Brain Health in the Fight Against Alzheimer's Disease

Healthy Cognition Clinical Trial

Official title:

Exercise for Brain Health in the Fight Against Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727360
• Other study ID #: 1115946
• Secondary ID: 1R01AG057552
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Cognition

Intervention

Other:
• Exercise Training
Supervised exercise conducted four days per week for six months.
• Flexibility Control
Supervised exercise conducted four days per week for six months.

Locations

Country	Name	City	State
United States	University of Maryland, Department of Kinesiology	College Park	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
University of Maryland, College Park	Johns Hopkins University, Marquette University, National Institute on Aging (NIA), University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5		Baseline and 6 months
Primary	Change from Baseline to 6 months in Resting Cerebral Blood Flow		Baseline and 6 months
Secondary	Change from Baseline to 6 months in VO2peak	Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness	Baseline and 6 months
Secondary	Change from Baseline to 6 months in 6 Minute Walk Test	Distance walked in 6 minutes	Baseline and 6 months