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Exercise for Cognitive Excellence in Parkinson's Disease | Clinical Trials | Clareo Health

RECRUITINGNA

Exercise for Cognitive Excellence in Parkinson's Disease

NCT05720468•University of California, San Francisco

Summary

This study will evaluate the safety and feasibility of a home-based, virtually-supervised, combined high intensity endurance and resistance training program in people with Parkinson's disease. It will also evaluate the effects of exercise on cognition and underlying exercise-related biological markers (biomarkers).

Detailed Description

Cognitive impairment begins early in Parkinson's disease (PD) and progresses to dementia in a majority of patients, impairing quality of life and contributing to growing health-related costs. Physical exercise has potent anti-aging effects and improves many outcomes in PD including cognition. Identifying biomarkers that respond to exercise, and how they associate with cognition and underlying disease pathology, may elucidate key mechanisms for countering cognitive decline. This is a randomized-controlled trial that evaluates safety and feasibility of a home-based exercise intervention in people with PD and measure its effects on cognition and circulating biomarkers of aging and stress. Thirty-two participants with PD will be randomized to receive a home-based, trainer-supervised endurance and resistance training program (exercise group) or no exercise (wait list control group) for 26 weeks. Cognitive assessments and patient reported outcomes will be obtained at baseline and at end of 26 weeks. Biomarkers in periphery (blood, saliva) and brain \[cerebrospinal fluid (CSF)\] will also be measured before and after the 26-week exercise intervention.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of idiopathic Parkinson's disease (PD) based on MDS criteria, with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.
•2. Modified Hoehn and Yahr stage less than 4
•3. Age 40-80 years at time of screening
•4. If being treated with PD symptomatic medications (i.e.g., rasagiline, carbidopa/levodopa, dopamine agonists, amantadine, anti-cholinergics), stable doses for greater than or equal to 2 months prior to baseline. If not being treated with PD symptomatic medication at time of screening, deemed unlikely to require symptomatic medication for next 6 months.

Exclusion Criteria

•1. A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
•2. A diagnosis of a significant neurological disease other than PD that would interfere with ability to perform study procedures or assessments.
•3. Significant cognitive impairment defined as Montreal Cognitive Assessment (MoCA)\<23 or any impairment that would, in the opinion of the investigator, interfere with ability to follow exercise directions.
•4. Beck Depression Inventory II (BDI) score \> 16, indicating depression that precludes ability to exercise.
•5. Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior to baseline visit, or any use within 30 days of baseline visit.
•6. Recent use of psychotropic medications (e.g., recent use of psychotropic medications (i.e., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for more than 30 days prior to screening.
•7. Presence of known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program.
•8. Presence of any of the following laboratory abnormalities on screening labs:
•1. Abnormal liver function (AST or ALT more than 2 times the upper limit of normal)
•2. Abnormal renal function (creatinine clearance calculated by the Cockcroft-Gault equation \<50mL/min or estimated glomerular filtration rate using the MDRD4 equation or the CKD-EPI equation \<45mL/min/1.73m2)
+17 more criteria

Locations (1)

University of California San Francisco

San Francisco, California, United States

Key Dates

Start Date

July 20, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

Exercise

OTHER

No Exercise

OTHER

Contacts

Nijee Luthra, MD, PhD

CONTACT

(415) 502-2960 nijee.luthra@ucsf.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exercise for Cognitive Excellence in Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

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