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ACTIVE NOT RECRUITING

NCT04748861

CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

The overall goal of the CYCLE-AD trial is to determine the role of long-term, high intensity exercise in slowing or delaying the onset of cognitive and AD-related brain changes in e4 carriers. Successful translation and demonstration of the effectiveness of a scalable home-based exercise intervention capable of slowing or delaying disease onset will transform AD treatment, improve patient outcomes and quality of life, and reduce health care costs.

Official title: CYCLE-AD: Randomized Controlled Trial to Assess the Efficacy of Indoor Cycling in Slowing Disease Progression in Healthy Older Persons at Genetic Risk for Alzheimer's Disease

Key Details

Gender

All

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-10-20

Completion Date

2026-12-31

Last Updated

2025-10-02

Healthy Volunteers

Yes

Conditions

High Intensity Exercise Normal Cognition Exercise Intervention

Interventions

OTHER

Indoor Cycling (IC)

Participants will ride a Peloton bike 3x/week for 18 months.

Inclusion Criteria: 1. Healthy elders, ages 65-80 years, inclusive 2. No cognitive impairment based on screening examination 3. APOE ε4 genotype 4. Inactive; defined as exercising less than 3x per week at moderate-vigorous intensity 5. Fluent in English (a requirement for neurocognitive testing) 6. Does not plan to travel for more than 2 consecutive weeks over the course of the study 7. Demonstrate ability to safely mount and dismount Peloton stationary cycle 8. In-home Wi-Fi (Peloton system requires Wi-Fi to transmit exercise data) 9. Medical clearance by the study doctor to participate in exercise program 10. Participant must meet Peloton height and weight safety requirements Exclusion Criteria: 1. Any significant neurologic disease, including dementia, mild cognitive impairment, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, stroke, multiple sclerosis, or history of significant head trauma with a reported loss of consciousness for greater than 30 minutes. 2. Significant medical illnesses/conditions that is unstable and/or uncontrolled (lung or kidney disease, cancer). 3. History of schizophrenia or bipolar disorder. 4. Major Depression within the past year. 5. History of alcohol or substance abuse or dependence within the past 2 years. 6. Current use of Alzheimer's disease medications, including cholinesterase inhibitors and memantine. 7. Any unstable or severe cardiovascular disease or asthmatic condition. 8. History of imaging confirmed transient ischemic attack or a score of \>4 on the modified Hachinski ischemic scale. 9. Significant abnormalities in laboratory blood tests that is considered to be a contraindication to exercise. 10. Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia). 11. A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States