The Effect of Donepezil on Gait and Balance in Parkinson's Disease

NCT ID: NCT01521117

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-07-31

Brief Summary

This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and muscle rigidity. Current medications for the treatment of PD do not improve gait and balance difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The investigators study will look at what aspects of gait and balance are improved by the study drug. The study drug is not approved to treat PD in the United States or other countries because we do not know enough about it.

Detailed Description

Parkinson's disease (PD) is a common neuro-degenerative disease affecting about 2% of the adult population in the United States over the age of 65. Some of the most disabling symptoms of Parkinson's disease are balance and gait dysfunction, leading to falls. These symptoms do not respond to current dopamine directed therapies. Evidence from both pathologic studies and advanced imaging has demonstrated that a cholinergic deficiency in the thalamus and basal ganglia is found in individuals with PD who fall compared to non-fallers. The central acting acetylcholine esterase inhibitor, donepezil, has been demonstrated to decrease falls in individuals with PD. The mechanism by which falls decreased is unknown. Our open label pilot data indicates that donepezil can improve quantitative measures of balance in individuals with PD. Suggesting that improvements in balance in the mechanism by which donepezil reduces falls. Our goal is to determine whether donepezil will:

• Improve quantitative measures of balance in subjects with Parkinson's disease compared to placebo.
• Improve quantitative measures of gait in subjects with Parkinson's disease compared to placebo.
• Improve cognitive measures in non-demented subjects with Parkinson's disease.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Donepezil, Then Placebo

Donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. After a washout period of 4 weeks, placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.

Group Type: EXPERIMENTAL

Donepezil

Intervention Type: DRUG

Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.

Placebo

Intervention Type: DRUG

Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.

Placebo, Then Donepezil

Placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.

After a washout period of 4 weeks, donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.

Group Type: EXPERIMENTAL

Donepezil

Intervention Type: DRUG

Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.

Placebo

Intervention Type: DRUG

Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.

Interventions

Donepezil

Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.

Intervention Type: DRUG

Placebo

Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.

Intervention Type: DRUG

Other Intervention Names

Aricept; Sugar Pill

Eligibility Criteria

Inclusion Criteria

• Idiopathic Parkinson's disease, defined by the UK Brain Bank criteria, with a Hoehn and Yahr score of 2 to 4
• Treated with levodopa for at least a year and on a stable antiparkinsonian regimen for at least one month
• Abnormal computerized dynamic posturography (CDP) on screening defined as a composite score below 65 (range 1-100)

Exclusion Criteria

• Dementia defined by MMSE less than 27
• Other medical conditions other than PD affecting balance or gait as determined by the investigators
• Unable to stand unassisted for 30 minutes
• Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic properties
• Medical or psychiatric co-morbidities that may interfere with compliance or might place subject in danger as determined by the investigators

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Amie Hiller, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth Kareus, MD

Role: PRINCIPAL_INVESTIGATOR

Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University

Locations

Parkinson's Center of Oregon - Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-7363

Identifier Type: -

Identifier Source: org_study_id