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CUPID

UnknownPhase 2

The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia

The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia

Lead sponsor

Inje University

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

150

estimated

Study population

Lewy body dementia

Key I/E criterion

•MMSE 10-24

Primary endpoint

•Mini-Mental State Examination (MMSE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCUPID-01

NCT IDNCT02415062

Timeline

Milestones

Study first posted2015-04-14estimated

Study start2015-07 (month precision)

Last update posted2015-08-06estimated

Primary completion2016-10estimated (month precision)

Study completion2017-12estimated (month precision)

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients diagnosed as Parkinson's disease according to Queen Brain Bank criteria

•Patients who have been diagnosed as dementia after diagnosing Parkinson's disease at least 1 year.

•Patients with Hoehn and Yahr staging from 2 to 4

•Patients with MMSE score from 10 to 24

•Patients who have taken donepezil for at least 12 weeks before screening period

•Patients whose medications for Parkinson's disease have not change for 1 month

•Patients who give informed consent

Exclusion criteria

•Patients who cannot be performed neuropsychiatric test because of hearing and visual difficulty

•Patients who have taken medicine affecting cognitive function such as anticholinergic drug and memantine -Patients diagnosed as dementia with Lewy body and vascular dementia-

•Patients who have history of neurosyphilis, head trauma, encephalitis or other movement disorders

•Patients who have psychiatric disease

•Except patients who are stable state under antidepressant or atypical neuroleptics

•Patients with child-bearing periods

•Patients who have severe liver or kidney disease necessary for aggressive treatment

•Patients who have gastrointestinal disease needed for treatment

•Patients who cannot taken tablet per oral

•Patients who are participated in other clinical trial except observational study

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Other (unclassified)

Executive function / language

Behavior / neuropsychiatric

Global cognition

3 endpoints

Primary/protocol endpoint

Korean Mini-Mental State Examination-2 (MMSE-2)

Time frame:24 weeks

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Clinical dementia rating

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Korean-Montreal Cognitive Assessment

Time frame:24 weeks

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Semantic fluency to evaluate neuropsychiatric symptoms

Time frame:24 weeks

descriptive

Function / daily living

3 endpoints

Secondary/protocol endpoint

Korean-Instrumental Activities of Daily Living

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Schwab & England Activities of Daily Living

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Global Deterioration Scale

Time frame:24 weeks

ratio, descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Caregiver-Administered Neuropsychiatric Inventory

Time frame:24 weeks

Neuropsychiatric Inventory (NPI)

categorical status, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Unified Parkinson's disease rating scale (UPDRS) part 3

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Modified Hoehn & Yahr stage

Time frame:24 weeks

categorical status, descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.