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CompletedPhase NA

Clinical Trial of Donepezil Between the Naive Group and the Switching Group

Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

72

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

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 ID2008-02-072
NCT IDNCT01023425

Timeline

Milestones

Study start2008-02 (month precision)
Primary completion2009-04actual (month precision)
Study completion2009-04actual (month precision)
Study first posted2009-12-02estimated
Last update posted2016-01-06estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA

2. Korean version Mini-Mental State Examination scores between 10 and 26

3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months

4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient

Exclusion criteria

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)

2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications

3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia

4. Clinically active cerebrovascular disease; History of seizure disorder

5. Other physical conditions that required acute treatment.

Endpoints (4)

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

Function / daily living
2
Global cognition
1
Behavior / neuropsychiatric
1

Global cognition

1 endpoint
Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)

Time frame:13 weeks, 26 weeks, 39 weeks, 52 weeks

ADAS-Cog

descriptive

Function / daily living

2 endpoints
Secondary/protocol endpoint

Seoul Activities of Daily Living (S-ADL)

Time frame:13 weeks, 26 weeks, 39 weeks, 52 weeks

descriptive

Secondary/protocol endpoint

Seoul-Instrumental Activities of Daily Living (S-IADL)

Time frame:13 weeks, 26 weeks, 39 weeks, 52 weeks

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Korean Neuropsychiatric Inventory (K-NPI)

Time frame:13 weeks, 26 weeks, 39 weeks, 52 weeks

Neuropsychiatric Inventory (NPI)

descriptive

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.