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

Primary Purpose

High Intensity Exercise, Normal Cognition, Exercise Intervention

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Indoor Cycling (IC)

About this trial

This is an interventional treatment trial for High Intensity Exercise focused on measuring APOE ε4 allele, indoor cycling, exercise intervention, healthy elders, genetic risk for Alzheimer's Disease

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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 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; Wi-Fi access rates exceed 80% in Cuyahoga county, Ohio households)
Medical clearance by their health care provider to participate in exercise program
Participant must meet Peloton height and weight safety requirements

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 (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 (complete blood count (CBC) with differential, B12, complete metabolic panel (CMP), LIPID PANEL, Westergren Sedimentation Rate, C-Reactive Proteins).
Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia).
A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Sites / Locations

Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Indoor Cycling (IC)

Usual and Customary Care (UCC)

Arm Description

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.

Participants engage in their habitual level of physical activity.

Outcomes

Primary Outcome Measures

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

Determine the effects of an IC intervention on cognitive functioning

Total Hippocampal Volume (THV)

Determine the effects of an IC intervention on MR brain imaging

V̇O2max

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04748861

First Posted

February 3, 2021

Last Updated

September 11, 2023

Sponsor

The Cleveland Clinic

Collaborators

National Institutes of Health (NIH), University of Maryland, College Park, National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04748861

Brief Title

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

Acronym

CYCLE-AD

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2021 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

National Institutes of Health (NIH), University of Maryland, College Park, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The apolipoprotein E epsilon 4 (APOE e4) allele is the most important genetic risk factor for late onset Alzheimer's disease (AD). A recent review by the World Health Organization highlighted the potential protective role of physical activity and exercise against cognitive decline, all-cause dementia, AD, and vascular dementia in healthy individuals. In an 18-month longitudinal observational study, investigators showed that sedentary e4 carriers experience significant declines in episodic memory and hippocampal volume compared to 4 carriers who engaged in moderate PA. Importantly, among 4 non-carriers, no significant longitudinal changes in cognition and brain imaging were observed whether the non-carriers were sedentary or engaged in moderate PA, suggesting that PA has a specific neuroprotective role in delaying the progression of AD in e4 carriers. Based on the results, a pragmatic, randomized controlled trial with blinded clinical and imaging outcomes is proposed to determine the impact of a home based, high intensity exercise intervention in healthy, cognitively intact e4 carriers between the ages of 65 and 80 years. The CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease) trial will recruit otherwise healthy sedentary carriers randomized to one of two groups (n=75 each): 1) an Indoor Cycling (IC) group that participates in high-intensity interval training (HIIT; 60-90% of heart rate reserve) in their home via the commercially available Peloton® cycling system or 2) a Usual and Customary Care (UCC) group, in which participants engage in their habitual level of PA. Investigators hypothesize that an 18-month high-intensity aerobic exercise regimen will slow AD-related disease progression in sedentary elders at genetic risk for AD. Participants in the intervention group will engage in exercise 3x/week (minimum 90 minutes/week) for 18 months. Primary outcome measures, obtained at study entry and at 18 months, will include comprehensive cognitive testing and brain MR imaging to assess disease progression and a comprehensive PA/fitness assessment to measure the degree of change in physical fitness due to high intensity aerobic exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Intensity Exercise, Normal Cognition, Exercise Intervention

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Indoor Cycling (IC)

Arm Type

Experimental

Arm Description

Arm Title

Usual and Customary Care (UCC)

Arm Type

No Intervention

Arm Description

Participants engage in their habitual level of physical activity.

Intervention Type

Other

Intervention Name(s)

Indoor Cycling (IC)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Determine the effects of an IC intervention on cognitive functioning

Time Frame

18 months

Title

Total Hippocampal Volume (THV)

Description

Determine the effects of an IC intervention on MR brain imaging

Time Frame

18 months

Title

V̇O2max

Description

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

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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. Significant abnormalities in laboratory blood tests that is considered to be a contraindication to exercise. Exclusion criteria specific to MR scanning (weight inappropriate for height, ferrous objects within the body, pregnancy, and a history of claustrophobia). A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen Rao, PhD

Phone

216-444-1025

raos2@ccf.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Rao, PhD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jay Alberts, PhD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephen Rao, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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