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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.
 
ClinicalTrials.gov Identifier: NCT02450786
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE May 14, 2015
First Posted Date  ICMJE May 21, 2015
Last Update Posted Date January 29, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
Rate of cognitive decline [ Time Frame: at 48wks ]
Korean Version of Mini-Mental State Exam
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • changes of cognitive decline [ Time Frame: baseline, 24 wks, 48 wks, 72 wks ]
  • changes of Parkinson's disease motor scale [ Time Frame: baseline, 24 wks, 48 wks, 72wks ]
    UPDRS part I-IV
  • Brain structure (cortical thickness and subcortical volume/shape) and Default mode network [ Time Frame: 48wks ]
    Conventional and functional brian MRI
  • brain functional connectivity [ Time Frame: 48wks ]
    digital electroencephalography
  • Comprehensive neuropsychological test [ Time Frame: 48wks ]
    Seoul Neuropsychological Screening Battery (SNSB)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Donepezil
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02450786
Other Study ID Numbers  ICMJE 4-2014-1089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP