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

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: Donepezil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Seth Kareus, MD, Principal Investigator, Affiliation: Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University

Overall contact:
Elizabeth Murdock, MS, Phone: 971-400-7504, Email: murdocke@ohsu.edu

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.

Clinical Details

Official title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: sensory organization test

Secondary outcome:

iTUG- measuring walking gait using inertial sensors

iTUG- measuring walking gait using inertial sensors

Concentration and Memory

Concentration and Memory

Sensory Organization Test

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Elizabeth Murdock, MS, Phone: 971-400-7504, Email: murdocke@ohsu.edu

Parkinson's Center of Oregon - Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Seth Kareus, MD, Email: kareus@ohsu.edu
Additional Information

Starting date: December 2011
Last updated: January 25, 2012

Page last updated: August 20, 2015

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