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

NCT04748861 | Active Not Recruiting DMC

• 2 other identifiers: IRB20-11981R01AG070736-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Intensity Exercise; Normal Cognition; Exercise Intervention

Keywords

APOE ε4 allele; indoor cycling; exercise intervention; healthy elders; genetic risk for Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Rey Auditory Verbal Learning Test Total Recall Trials 1-5 (RAVLT1-5).

  Determine the effects of an IC intervention on cognitive functioning

  18 months

• Total Hippocampal Volume (THV)

  Determine the effects of an IC intervention on MR brain imaging

  18 months

• V̇O2max

  Determine the effects of an IC intervention on PA/fitness testing

  18 months

Study Arms (2)

Indoor Cycling (IC)

EXPERIMENTAL

Participants will engage in high-intensity interval training (HIIT; 60-90% of heart rate reserve) in their home via the commercially available Peloton® cycling system or 2) 3x/week (minimum 90 minutes/week) for 18 months.

Other: Indoor Cycling (IC)

Usual and Customary Care (UCC)

NO INTERVENTION

Participants engage in their habitual level of physical activity.

Interventions

Indoor Cycling (IC) OTHER

Participants will ride a Peloton bike 3x/week for 18 months.

Indoor Cycling (IC)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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 may not qualify 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.
• A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institutes of Health (NIH): collaborator
• University of Maryland, College Park: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Stephen Rao, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Jay Alberts, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A pragmatic, randomized controlled trial with blinded clinical and imaging outcomes

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 10, 2021
• Study Start: October 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)