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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01521117 |
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Date of registration:
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12/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Donepezil on Gait and Balance in Parkinson's Disease
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Scientific title:
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A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's Disease |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01521117 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Seth Kareus, MD |
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Address:
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Telephone:
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Email:
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kareus@ohsu.edu |
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Affiliation:
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Name:
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Elizabeth Murdock, MS |
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Address:
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Telephone:
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971-400-7504 |
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Email:
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murdocke@ohsu.edu |
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Affiliation:
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Name:
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Seth Kareus, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Donepezil
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Primary Outcome(s)
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sensory organization test
[Time Frame: Day 1 and Day 42]
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Secondary Outcome(s)
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iTUG- measuring walking gait using inertial sensors
[Time Frame: visit day 1 and day 42]
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Concentration and Memory
[Time Frame: Day 1 and day 42]
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Concentration and Memory
[Time Frame: Day 70 and day 112]
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Sensory Organization Test
[Time Frame: Day 70 through 112]
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iTUG- measuring walking gait using inertial sensors
[Time Frame: Day 70 and Day 112]
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Secondary ID(s)
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OHSU-7363
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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