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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02450786
• Other study ID #: 4-2014-1089
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: August 2019

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cognitive decline	Korean Version of Mini-Mental State Exam	at 48wks
Secondary	changes of cognitive decline		baseline, 24 wks, 48 wks, 72 wks
Secondary	changes of Parkinson's disease motor scale	UPDRS part I-IV	baseline, 24 wks, 48 wks, 72wks
Secondary	Brain structure (cortical thickness and subcortical volume/shape) and Default mode network	Conventional and functional brian MRI	48wks
Secondary	brain functional connectivity	digital electroencephalography	48wks
Secondary	Comprehensive neuropsychological test	Seoul Neuropsychological Screening Battery (SNSB)	48wks