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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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12 December 2020 |
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Main ID: |
NCT02206620 |
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Date of registration:
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29/07/2014 |
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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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Effects of Cholinergic Augmentation on Measures of Balance and Gait
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Scientific title:
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Effects of Cholinergic Augmentation on Measures of Balance and Gait |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02206620 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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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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John Nutt, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 30 years old or older
- Diagnosis of idiopathic Parkinson's disease
- Stand unassisted (without use of an assistance device) and walk continuously for at
least 2 minutes.
Exclusion Criteria:
- musculoskeletal disorders that affect standing and walking
- Uncorrected vision disturbance
- Vestibular problems
- Major depression
- Hallucinations or other psychiatric disturbances
- Tachycardia
- Bradycardia
- Arrhythmias
- Peptic ulcer disease
- Use of anticholinergics
- Use of cholinesterase inhibitors
- Use of bladder antispasmodics
- Use of tricyclic antidepressants
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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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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Delta Medio-lateral Postural Sway Range (Foam)
[Time Frame: Six weeks]
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Delta of the Variability of Stride Time While Walking
[Time Frame: Six weeks]
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Secondary Outcome(s)
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Short-latency Afferent Inhibition is a Marker of Cortical Cholinergic Activity
[Time Frame: Six weeks]
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Attention Network Test
[Time Frame: Six weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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