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High-Intensity Exercise for Alzheimer's Disease (CYCLE-AD Trial)

N/A
Recruiting
Led By Stephen Rao, PhD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

CYCLE-AD Trial Summary

This trial is testing whether long-term, high intensity exercise can slow or delay the onset of Alzheimer's disease in people who are at risk for it.

Who is the study for?
The CYCLE-AD trial is for healthy elders aged 65-80 with no cognitive impairment, carrying the APOE ε4 gene. Participants should be inactive (exercising less than three times a week), fluent in English, able to use a Peloton bike safely, and have in-home Wi-Fi. They must not have severe medical conditions or plan extensive travel during the study.Check my eligibility
What is being tested?
This trial tests if long-term high-intensity indoor cycling can slow down or delay Alzheimer's-related brain changes in e4 carriers. It involves using a home-based Peloton exercise program to see if it can improve patient outcomes and reduce healthcare costs related to Alzheimer's Disease.See study design
What are the potential side effects?
While specific side effects are not listed for this exercise intervention, participants may experience typical exercise-related issues such as muscle soreness, fatigue, joint pain or injury risk associated with high-intensity workouts.

CYCLE-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not plan to travel for more than 2 weeks during the study.
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I can safely get on and off a stationary bike by myself.
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I have the APOE ε4 gene.
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I am between 65 and 80 years old and in good health.

CYCLE-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rey Auditory Verbal Learning Test Total Recall Trials 1-5 (RAVLT1-5).
Total Hippocampal Volume (THV)
V̇O2max

CYCLE-AD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Indoor Cycling (IC)Experimental Treatment1 Intervention
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.
Group II: Usual and Customary Care (UCC)Active Control1 Intervention
Participants engage in their habitual level of physical activity.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,022 Previous Clinical Trials
1,365,600 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,646 Total Patients Enrolled
University of Maryland, College ParkOTHER
154 Previous Clinical Trials
45,335 Total Patients Enrolled

Media Library

Exercise Intervention Research Study Groups: Indoor Cycling (IC), Usual and Customary Care (UCC)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor include individuals who are over 35 years old?

"In accordance with the inclusion criteria, this clinical trial permits patients aged 65 to 80."

Answered by AI

How can I become a participant in this medical experiment?

"This medical trial seeks to recruit 150 senior patients, aged 65-80 and suffering from Alzheimer's disease. Additionally, they must be healthy, lack cognitive impairment as measured by a screening exam, possess an APOE ε4 genotype, not exercise more than 3 times per week at moderate-vigorous intensity levels. Moreover all enrollees must be fluent in English for neurocognitive testing purposes; have access to Wi-Fi with which the Peloton system will transmit data (a common amenity across Cuyahoga county homes); receive medical clearance to partake in the program; meet Peloton safety requirements; commit to residing nearby"

Answered by AI

Is this clinical trial still recruiting patients?

"Affirmative. The particulars available on clinicaltrials.gov indicates that this medical trial is actively recruiting now, with the initial post date of October 20th 2021 and latest amendment being made on October 31st 2022. A total of 150 patients are required to be enrolled from a single site."

Answered by AI

How many individuals are participating in the investigation?

"Affirmative. Clinicaltrials.gov provides evidence that, since its posting on October 20th 2021, this clinical trial is actively searching for 150 patients at a solitary medical centre."

Answered by AI
~63 spots leftby Dec 2025