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CompletedPhase NA

Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)

Lead sponsor

Osaka University

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE 10-26

Primary endpoint

•FDG-PET

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

NCT IDNCT00776347

Org study IDOSK-08096

Timeline

Milestones

Study start2008-10 (month precision)

Study first posted2008-10-21estimated

Primary completion2015-02actual (month precision)

Study completion2015-02actual (month precision)

Last update posted2015-10-15estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

DLB patients:

•who fulfill the diagnostic criteria of DLB

•60 to 85 years old

•right-handed

•Clinical Dementia Rating (CDR) ≧ 0.5

•Mini Mental State Examination (MMSE) score from 10 to 26

Normal Controls:

•who are independent

•who have no subjective or objective cognitive impairment

•60 to 85 years old

•right-handed

•MMSE score over 24

Exclusion criteria

DLB patients:

•who have diabetes mellitus

•who have pathological change on MRI other than brain atrophy

•who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function

•who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety

•who have severe digestive ulcus

•who have severe bronchitic asthma or obstructive lung disease

•who have no caregiver who knows patient's condition well

Normal Controls:

•who have diabetes mellitus

•who have taken donepezil before

•who have abnormal findings on MRI

•who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function

Endpoints (2)

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

Neuroimaging

Global cognition

1 endpoint

Secondary/protocol endpoint

Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver

Time frame:14 weeks

descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

FDG-PET

Time frame:14 weeks

descriptive

Publications (1)

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

Kanemoto H, Kazui H, Adachi H, Yoshiyama K, Wada T, Nomura KT, Shimosegawa E, Ikeda M. Thalamic pulvinar metabolism, sleep disturbances, and hallucinations in dementia with Lewy bodies: Positron emission tomography and actigraphy study. Int J Geriatr Psychiatry. 2020 Aug;35(8):934-943. doi: 10.1002/gps.5315. Epub 2020 Jun 8.
PMID32346907via DERIVED

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.