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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seth Kareus, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01521117
First received: January 12, 2012
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Donepezil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • sensory organization test [ Time Frame: Day 1 and Day 42 ] [ Designated as safety issue: No ]
    to measure changes in balance pre and post intervention a neurocom sensory organization test will be performed. Overall score will assess whether there are improvements in balance abilities using vision and changes in the forceplate movement under subjects feet.


Secondary Outcome Measures:
  • iTUG- measuring walking gait using inertial sensors [ Time Frame: Day 70 and Day 112 ] [ Designated as safety issue: No ]
    Measuring changes in ability to stand from sitting position, walking 7 meters, then walking back returning to the chair. Inertial sensors measure changes in acceleration and velocity.

  • iTUG- measuring walking gait using inertial sensors [ Time Frame: visit day 1 and day 42 ] [ Designated as safety issue: No ]
    Measuring changes in ability to stand from sitting position, walking 7 meters, then walking back returning to the chair. Inertial sensors measure changes in acceleration and velocity.

  • Concentration and Memory [ Time Frame: Day 1 and day 42 ] [ Designated as safety issue: No ]
    series of cogntive tests including the stroop test for evaluating thinking and concentrating ability. Trails making test for evaluating thinking and contrating ability. Mini-Mental State Exam which measures memory and thinking ability.

  • Concentration and Memory [ Time Frame: Day 70 and day 112 ] [ Designated as safety issue: No ]
    series of cogntive tests including the stroop test for evaluating thinking and concentrating ability. Trails making test for evaluating thinking and contrating ability. Mini-Mental State Exam which measures memory and thinking ability.

  • Sensory Organization Test [ Time Frame: Day 70 through 112 ] [ Designated as safety issue: No ]
    to measure changes in balance pre and post intervention a neurocom sensory organization test will be performed. Overall score will assess whether there are improvements in balance abilities using vision and changes in the forceplate movement under subjects feet.


Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donepezil, washout period, placebo Drug: Donepezil
Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.
Other Name: Aricept
Experimental: Placebo, washout period, Donepezil Drug: Donepezil
Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.
Other Name: Aricept

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521117

Contacts
Contact: Elizabeth Murdock, MS 971-400-7504 murdocke@ohsu.edu

Locations
United States, Oregon
Parkinson's Center of Oregon - Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Seth Kareus, MD       kareus@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Seth Kareus, MD Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Seth Kareus, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01521117     History of Changes
Other Study ID Numbers: OHSU-7363
Study First Received: January 12, 2012
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
donepezil
parkinson's disease
balance
cholinesterase inhibitor

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014