Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
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|ClinicalTrials.gov Identifier: NCT02450786|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : January 29, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
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.
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.
- Rate of cognitive decline [ Time Frame: at 48wks ]Korean Version of Mini-Mental State Exam
- 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)
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 ClinicalTrials.gov identifier (NCT number): NCT02450786
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|