ACTIVE_NOT_RECRUITING

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

Conditions

High Intensity Exercise Normal Cognition Exercise Intervention APOE ε4 allele indoor cycling healthy elders genetic risk for Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-20

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04748861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy elders, ages 65-80 years, inclusive 2. No cognitive impairment based on screening examination 3. APOE ε4 genotype 4. Inactive; defined as exercising less than 3x per week at moderate-vigorous intensity 5. Fluent in English (a requirement for neurocognitive testing) 6. Does not plan to travel for more than 2 consecutive weeks over the course of the study 7. Demonstrate ability to safely mount and dismount Peloton stationary cycle 8. In-home Wi-Fi (Peloton system requires Wi-Fi to transmit exercise data) 9. Medical clearance by the study doctor to participate in exercise program 10. Participant must meet Peloton height and weight safety requirements	1. 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. 2. Significant medical illnesses/conditions that is unstable and/or uncontrolled (lung or kidney disease, cancer). 3. History of schizophrenia or bipolar disorder. 4. Major Depression within the past year. 5. History of alcohol or substance abuse or dependence within the past 2 years. 6. Current use of Alzheimer's disease medications, including cholinesterase inhibitors and memantine. 7. Any unstable or severe cardiovascular disease or asthmatic condition. 8. History of imaging confirmed transient ischemic attack or a score of \>4 on the modified Hachinski ischemic scale. 9. Significant abnormalities in laboratory blood tests that is considered to be a contraindication to exercise. 10. Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia). 11. A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Inclusion Criteria

Exclusion Criteria

1. Healthy elders, ages 65-80 years, inclusive
2. No cognitive impairment based on screening examination
3. APOE ε4 genotype
4. Inactive; defined as exercising less than 3x per week at moderate-vigorous intensity
5. Fluent in English (a requirement for neurocognitive testing)
6. Does not plan to travel for more than 2 consecutive weeks over the course of the study
7. Demonstrate ability to safely mount and dismount Peloton stationary cycle
8. In-home Wi-Fi (Peloton system requires Wi-Fi to transmit exercise data)
9. Medical clearance by the study doctor to participate in exercise program
10. Participant must meet Peloton height and weight safety requirements

1. 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.
2. Significant medical illnesses/conditions that is unstable and/or uncontrolled (lung or kidney disease, cancer).
3. History of schizophrenia or bipolar disorder.
4. Major Depression within the past year.
5. History of alcohol or substance abuse or dependence within the past 2 years.
6. Current use of Alzheimer's disease medications, including cholinesterase inhibitors and memantine.
7. Any unstable or severe cardiovascular disease or asthmatic condition.
8. History of imaging confirmed transient ischemic attack or a score of \>4 on the modified Hachinski ischemic scale.
9. Significant abnormalities in laboratory blood tests that is considered to be a contraindication to exercise.
10. Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia).
11. A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Contacts and Locations

Principal Investigator

Stephen Rao, PhD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Jay Alberts, PhD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Stephen Rao, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
Jay Alberts, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-20

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-10-20

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

High Intensity Exercise
Normal Cognition
Exercise Intervention