Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease
NCT ID: NCT03011476
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2017-04-11
2018-12-30
Brief Summary
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Detailed Description
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1. Assessment:
* Overall features of PD are assessed by Unified Parkinson Disease Rating Scale (UPDRS). Non-motor features including cognition will be assessed by standard scales. Gait and balance will be assessed by gait analysis system, which measures physiological parameters of gait such as velocity, variability and center of pressure. Positron emission tomography using 18F-fluorodeoxyglucose (FDG PET) will be done to brain activities related to gait and balance.
* Clinical evaluation will be done at the baseline, 4th, 8th and 12th week
* Gait analysis and FDG PET will be done at the baseline and 12th week
2. Drug dosage
* For the first 4 weeks, 5 mg/day
* Then, 10 mg/day for 8 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Donepezil
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
Donepezil
1. Start with 5 mg/day for 4 weeks
2. Increased to 10 mg/day for 8 weeks
Placebos
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
Placebos
1. Start with 5 mg/day for 4 weeks
2. Increased to 10 mg/day for 8 weeks
Interventions
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Donepezil
1. Start with 5 mg/day for 4 weeks
2. Increased to 10 mg/day for 8 weeks
Placebos
1. Start with 5 mg/day for 4 weeks
2. Increased to 10 mg/day for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postural instability and gait disturbance phenotype
* Hoehn and Yahr stage ≤ 3
* Mini-Mental status examination ≥ 24
Exclusion Criteria
* Drugs related to acetylcholine metabolism
40 Years
75 Years
ALL
No
Sponsors
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Kyung Hee University Hospital
OTHER
Responsible Party
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Tae-Beom Ahn
Professor
Principal Investigators
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Tae-Beom Ahn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital
Locations
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Kyung Hee Universtiy Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Bohnen NI, Frey KA, Studenski S, Kotagal V, Koeppe RA, Scott PJ, Albin RL, Muller ML. Gait speed in Parkinson disease correlates with cholinergic degeneration. Neurology. 2013 Oct 29;81(18):1611-6. doi: 10.1212/WNL.0b013e3182a9f558. Epub 2013 Sep 27.
Henderson EJ, Lord SR, Brodie MA, Gaunt DM, Lawrence AD, Close JC, Whone AL, Ben-Shlomo Y. Rivastigmine for gait stability in patients with Parkinson's disease (ReSPonD): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Mar;15(3):249-58. doi: 10.1016/S1474-4422(15)00389-0. Epub 2016 Jan 13.
Henderson EJ, Lord SR, Close JC, Lawrence AD, Whone A, Ben-Shlomo Y. The ReSPonD trial--rivastigmine to stabilise gait in Parkinson's disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson's disease who have fallen. BMC Neurol. 2013 Dec 3;13:188. doi: 10.1186/1471-2377-13-188.
Bohnen NI, Muller ML, Koeppe RA, Studenski SA, Kilbourn MA, Frey KA, Albin RL. History of falls in Parkinson disease is associated with reduced cholinergic activity. Neurology. 2009 Nov 17;73(20):1670-6. doi: 10.1212/WNL.0b013e3181c1ded6.
Montero-Odasso M, Muir-Hunter SW, Oteng-Amoako A, Gopaul K, Islam A, Borrie M, Wells J, Speechley M. Donepezil improves gait performance in older adults with mild Alzheimer's disease: a phase II clinical trial. J Alzheimers Dis. 2015;43(1):193-9. doi: 10.3233/JAD-140759.
Stebbins GT, Goetz CG, Burn DJ, Jankovic J, Khoo TK, Tilley BC. How to identify tremor dominant and postural instability/gait difficulty groups with the movement disorder society unified Parkinson's disease rating scale: comparison with the unified Parkinson's disease rating scale. Mov Disord. 2013 May;28(5):668-70. doi: 10.1002/mds.25383. Epub 2013 Feb 13.
Other Identifiers
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2016-08-030-003
Identifier Type: -
Identifier Source: org_study_id
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