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Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00912808
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : August 15, 2011
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kathryn Anne Chung, Oregon Health and Science University

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: Donepezil Drug: Sugar Pill (placebo) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's
Study Start Date : October 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Fall Frequency Per Day [ Time Frame: 6 weeks ]
    The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.


Secondary Outcome Measures :
  1. Frequency of Near Falls Per Day [ Time Frame: 6 weeks ]
    The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912808


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

Responsible Party: Kathryn Anne Chung, Associate Professor - Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00912808     History of Changes
Other Study ID Numbers: e1784
First Posted: June 3, 2009    Key Record Dates
Results First Posted: August 15, 2011
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kathryn Anne Chung, 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
Donepezil
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents