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Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02450786
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : January 29, 2019
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

There have been growing interest in identifying Parkinson's disease (PD) patients with mild cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels, in which suggest the existence of something common with Alzheimer's dementia. PDD have showed more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in DLB and PDD. This supports the hypothesis that the two disorders are closely related clinically and neurobiologically. Larger scale, placebo controlled clinical trials are needed to provide an evidence base to guide the clinical use of cholinesterase inhibitors in Lewy body disease.

It is believed that earlier intervention, later appearance of dementia should be needed to lower the socioeconomic costs and to improve the quality of life on patients and caregivers. The investigators anticipate that donepezil may delay the development of dementia in patients with PD-MCI.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Donepezil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Donepezil group
Donepezil is started in 5mg for 8 weeks followed by dose escalation to 10mg and then maintained for 40 weeks. Participants who are not tolerable to dose of 10mg due to any issues of adverse effects would be maintained with donepezil 5mg exclusively in remained period.
Drug: Donepezil
Donepezil is started in patients with Parkinson's disease mild cognitive impairment with 5mg for 8 weeks followed by dose up to 10mg and then maintained for 40 weeks. Participants who are not tolerable to dose of 10mg due to any issues of adverse effects would be maintained with donepezil 5mg exclusively in remained period.

No Intervention: control group
No administration of any therapeutic medications for dementia including cholinesterase inhibitor or NMDA receptor blocking agents. Standard treatment protocol of Parkinson's disease with mild cognitive impairment would be fulfilled including dopaminergic or nondopaminergic medications as well as nootropic drugs.

Primary Outcome Measures :
  1. Rate of cognitive decline [ Time Frame: at 48wks ]
    Korean Version of Mini-Mental State Exam

Secondary Outcome Measures :
  1. changes of cognitive decline [ Time Frame: baseline, 24 wks, 48 wks, 72 wks ]
  2. changes of Parkinson's disease motor scale [ Time Frame: baseline, 24 wks, 48 wks, 72wks ]
    UPDRS part I-IV

  3. Brain structure (cortical thickness and subcortical volume/shape) and Default mode network [ Time Frame: 48wks ]
    Conventional and functional brian MRI

  4. brain functional connectivity [ Time Frame: 48wks ]
    digital electroencephalography

  5. Comprehensive neuropsychological test [ Time Frame: 48wks ]
    Seoul Neuropsychological Screening Battery (SNSB)

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age more than 40 years old
  • Clinical diagnosis of PD established by Queen Square Brain Bank Criteria
  • Stable dose of levodopa at least 3 months before the study enrollment
  • Diagnosis of MCI in PD according to the Movement Disorder Society (MDS) task force guideline

Exclusion Criteria:

  • Diagnosis of Dementia
  • Hypersensitivity to piperidine derivatives
  • Concomitant anticholinergics and cholinergic agents
  • Severe cardiac arrhythmia: Sick sinus syndrome, complete AV block, Uncontrolled arrhythmia, history of ventricular fibrillation

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 identifier (NCT number): NCT02450786

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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University Identifier: NCT02450786    
Other Study ID Numbers: 4-2014-1089
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents