CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease) (NCT04748861) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)
United States150 participantsStarted 2021-10-20
Plain-language 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.
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rey Auditory Verbal Learning Test Total Recall Trials 1-5 (RAVLT1-5).
. In-home Wi-Fi (Peloton system requires Wi-Fi to transmit exercise data)
Exclusion criteria
. 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.