NCT04748861 · ACTIVE NOT RECRUITING
CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)
CYCLE-AD is testing whether long-term, high-intensity indoor cycling on a home-based Peloton bike can slow or delay cognitive decline and Alzheimer's-related brain changes in older adults who carry the APOE4 gene. Researchers will track brain changes and cognitive performance over time. This is a Phase NA trial, meaning it is a behavioral or device study rather than a drug trial, focused on measuring real-world effectiveness of the exercise program.
You may qualify if
- Healthy elders, ages 65-80 years, inclusive
- No cognitive impairment based on screening examination
- APOE ε4 genotype
- Inactive; defined as exercising less than 3x per week at moderate-vigorous intensity
- Fluent in English (a requirement for neurocognitive testing)
- Does not plan to travel for more than 2 consecutive weeks over the course of the study
- Demonstrate ability to safely mount and dismount Peloton stationary cycle
- In-home Wi-Fi (Peloton system requires Wi-Fi to transmit exercise data)
- Medical clearance by the study doctor to participate in exercise program
- Participant must meet Peloton height and weight safety requirements
You're excluded if
- 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.
- Significant medical illnesses/conditions that is unstable and/or uncontrolled (lung or kidney disease, cancer).
- History of schizophrenia or bipolar disorder.
- Major Depression within the past year.
- History of alcohol or substance abuse or dependence within the past 2 years.
- Current use of Alzheimer's disease medications, including cholinesterase inhibitors and memantine.
- Any unstable or severe cardiovascular disease or asthmatic condition.
- History of imaging confirmed transient ischemic attack or a score of >4 on the modified Hachinski ischemic scale.
- Significant abnormalities in laboratory blood tests that is considered to be a contraindication to exercise.
- Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia).
- A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-10-02