Clinical trial NCT01521117: The Effect of Donepezil on Gait and Balance in Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: donepezil
parkinson's disease
balance
cholinesterase inhibitor
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sensory Organization Test - Composite Score
timeFrame: Change from Day 1 of each treatment phase to Day 42 of each treatment phase
measure: Sensory Organization Test (SOT) - Condition 4 (Eyes Open, Moving Surround, Stable Platform).
timeFrame: Change from Day 1 of each treatment phase to Day 42 of each treatment phase
Secondary outcomes:
measure: Trails B - A
timeFrame: Change from Day 1 of each treatment phase to Day 42 of each treatment phase
Other outcomes:
Locations:
city: Portland
country: United States
facility: Parkinson's Center of Oregon - Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University
name: Seth Kareus, MD
role: PRINCIPAL_INVESTIGATOR
References: