CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)
Launched by THE CLEVELAND CLINIC · Feb 9, 2021
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The CYCLE-AD trial is a research study looking at whether long-term, high-intensity exercise can help slow down or delay changes in the brain related to Alzheimer’s disease (AD) in older adults who carry a specific gene called APOE ε4. This study aims to see if an exercise program that people can do at home, using a Peloton stationary bike, can improve the health and quality of life for participants while also potentially lowering healthcare costs associated with Alzheimer's treatment.
To be eligible for this study, participants should be healthy adults aged 65 to 80, who do not have any cognitive impairments and are not currently exercising regularly (less than three times a week). They must also be fluent in English and have access to in-home Wi-Fi. Participants will need medical clearance to ensure they can safely participate in the exercise program. Throughout the trial, individuals will engage in a structured exercise routine and will be monitored to assess the impact of this intervention on their cognitive health. It’s important to note that individuals with certain medical conditions or those currently taking Alzheimer’s medications cannot participate in this study.
Gender
ALL
Eligibility criteria
- 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
About The Cleveland Clinic
The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Stephen Rao, PhD
Principal Investigator
The Cleveland Clinic
Jay Alberts, PhD
Principal Investigator
The Cleveland Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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