Exercise Intervention / Normal Cognition / High Intensity Exercise · Interventional Study

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

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is an active interventional trial registered but not yet reporting results. The CYCLE-AD study is examining whether home-based high-intensity indoor cycling slows cognitive decline or delays Alzheimer's-related brain changes in cognitively normal APOE4 carriers over 18 months, using surrogate endpoints including memory, hippocampal volume, and aerobic fitness.

What was studied

Interventional, Randomized, Parallel, Triple masking, Treatment purpose. High Intensity Exercise, Normal Cognition, Exercise Intervention; age from 65 Years; to 80 Years; accepts healthy volunteers. Intervention: Indoor Cycling (IC). Compared with: Usual and Customary Care (UCC) — No Intervention. n = 150. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Active trial with no results yet reported; early-phase intervention study in cognitively normal e4 carriers examining surrogate endpoints of cognition and brain volume.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Rey Auditory Verbal Learning Test Total Recall Trials 1-5 (RAVLT1-5). (assessed at 18 months); Total Hippocampal Volume (THV) (assessed at 18 months); V̇O2max (assessed at 18 months)

DesignInterventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationHigh Intensity Exercise, Normal Cognition, Exercise Intervention; age from 65 Years; to 80 Years; accepts healthy volunteers

Sample size150

InterventionIndoor Cycling (IC)

ComparatorUsual and Customary Care (UCC) — No Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Enrollment150

Primary outcome measure 1Rey Auditory Verbal Learning Test Total Recall Trials 1-5 (RAVLT1-5) at 18 months

Primary outcome measure 2Total Hippocampal Volume (THV) at 18 months

Primary outcome measure 3V̇O2max at 18 months

Caveats

No results reported in this registry record; trial remains active and not recruiting.
Control or comparator arm not described in this registry record.
Blinding and allocation concealment methods not stated.
Follow-up period is 18 months; long-term cognitive or clinical outcomes not yet available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional design with exercise intervention; phase not specified; no comparator arm described.

Directness

limited

Primary outcomes are surrogate endpoints (cognitive test, hippocampal volume, aerobic capacity), not clinical disease onset.

Consistency

insufficient

Registry record only; no results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or control group; cannot assess bias.

Sample adequacy

moderate

150 participants enrolled; appropriate for pilot cognitive intervention trial but limited for definitive claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04748861). This is a study registration, not published results. Lead sponsor: The Cleveland Clinic. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 150 participants (ACTUAL). Conditions: High Intensity Exercise, Normal Cognition, Exercise Intervention. Interventions: OTHER: Indoor Cycling (IC). Primary outcome measures: Rey Auditory Verbal Learning Test Total Recall Trials 1-5 (RAVLT1-5). , 18 months; Total Hippocampal Volume (THV) , 18 months; V̇O2max , 18 months. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Exercise InterventionNormal CognitionNCT04748861High Intensity ExerciseIndoor Cycling (IC)The Cleveland Clinic