High intensity exercise to slow Alzheimer's disease effects
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
NA · The Cleveland Clinic · NCT04748861
This study is testing if a home-based high-intensity exercise program can help older adults at risk for Alzheimer's disease slow down cognitive decline.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04748861 on ClinicalTrials.gov |
What this trial studies
The CYCLE-AD trial aims to evaluate the impact of a home-based high intensity exercise program on cognitive decline in healthy older adults who carry the APOE ε4 allele, a genetic risk factor for Alzheimer's disease. Participants aged 65-80 will be randomized into two groups, with one group engaging in high-intensity interval training using a Peloton stationary bike. The study will assess cognitive and brain imaging outcomes over an 18-month period to determine if this exercise intervention can delay the onset of Alzheimer's-related changes. The findings could lead to scalable exercise programs that improve quality of life and reduce healthcare costs for at-risk populations.
Who should consider this trial
Good fit: Ideal candidates are healthy elders aged 65-80 who are APOE ε4 carriers and currently inactive.
Not a fit: Patients with significant neurological diseases or cognitive impairments will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly delay the onset of cognitive decline and Alzheimer's disease in genetically at-risk individuals.
How similar studies have performed: Previous studies have indicated the protective role of physical activity against cognitive decline, suggesting potential success for this exercise intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Stephen Rao, PhD — The Cleveland Clinic
- Study coordinator: Stephen Rao, PhD
- Email: raos2@ccf.org
- Phone: 216-444-1025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High Intensity Exercise, Normal Cognition, Exercise Intervention, APOE ε4 allele, indoor cycling, exercise intervention, healthy elders, genetic risk for Alzheimer's Disease