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Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00912808
First received: June 2, 2009
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.


Condition Intervention
Parkinson's Disease
 Drug: Donepezil
Drug: Sugar Pill (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Fall Frequency Per Day [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The primary outcomes were fall and near-fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for one week of monitoring, and collected for six weeks per phase. Postcards were mailed back to the investigator weekly.


Secondary Outcome Measures:
  • Frequency of Near Falls Per Day [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donepezil Drug: Donepezil
donepezil, 5 mg, capsule, once a day, 3 weeks
Other Name: aricept
Placebo Comparator: Sugar Pill Drug: Sugar Pill (placebo)
sugar pill, one capsule, once a day, 3 weeks

Detailed Description:

This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 21
  • Diagnosis of Parkinson's disease
  • Treated with dopaminergic medication for at least 1 year

Exclusion Criteria:

  • Must be ambulatory (can use walker or cane)
  • No obvious remediable cause of falls
  • Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)
  • Dementia present (MMSE < 25)
  • Not taking cholinergic or anticholinergic medications 10 days prior to screening visit
  • No Warfarin use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912808

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kathryn Chung, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Kathryn Chung, MD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00912808     History of Changes
Other Study ID Numbers: e1784
Study First Received: June 2, 2009
Results First Received: July 20, 2011
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
parkinsons disease
falling

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

ClinicalTrials.gov processed this record on May 22, 2013