Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Donepezil
Sugar Pill (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring parkinsons disease, falling
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Donepezil
Sugar Pill
Arm Description
Outcomes
Primary Outcome Measures
Fall Frequency Per Day
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
Frequency of Near Falls Per Day
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.
Full Information
NCT ID
NCT00912808
First Posted
June 2, 2009
Last Updated
April 5, 2018
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00912808
Brief Title
Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
Official Title
A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
parkinsons disease, falling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Donepezil
Arm Type
Experimental
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
aricept
Intervention Description
donepezil, 5 mg, capsule, once a day, 3 weeks
Intervention Type
Drug
Intervention Name(s)
Sugar Pill (placebo)
Intervention Description
sugar pill, one capsule, once a day, 3 weeks
Primary Outcome Measure Information:
Title
Fall Frequency Per Day
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Frequency of Near Falls Per Day
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Chung, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
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