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NCT04748861Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
150 (actual)
First submitted
3 Feb 2021
Start date
20 Oct 2021
Primary completion date
31 Dec 2026
Lead sponsor
The Cleveland Clinic
NCT number
NCT04748861

What you commit to

  • Study type: Interventional
  • Participants enrolled: 150
  • From 20 Oct 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • 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.
  • Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia).

Lab values

  • Significant abnormalities in laboratory blood tests that is considered to be a contraindication to exercise.

Other

  • Major Depression within the past year.
  • A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Who the study is looking for

  • 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

Age in the registry: 65 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.