CompletedPhase 2Results posted

A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Lead sponsor

Eisai Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 1-12

Primary endpoint

•Cmax of E2020 on Visits 2 and 3

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 IDE2020-J081-221

NCT IDNCT01276353

Timeline

Milestones

Study start2011-01 (month precision)

Study first posted2011-01-13estimated

Primary completion2012-04actual (month precision)

Study completion2012-04actual (month precision)

Results first posted2014-08-01estimated

Last update posted2014-08-08estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnostic evidence of probable Alzheimer's disease (AD) consistent with the Diagnostic and Statistical Manual for Mental Disorders-version IV (DSM-IV)

•Hachinski Ischemic Score

•Functional Assessment Staging (FAST) scale greater than or equal to 6 at Screening.

•Mini-Mental State Examination (MMSE) score of 1 to 12 at Screening

•Subjects who are on a stable Aricept- dose of 10 mg immediate release (IR), taken as a single, daily dose for 3 months prior to the Screening Visit

•Evidence consistent with Alzheimer's disease (AD) on any cranial image on magnetic resonance imaging (MRI) or computed tomography (CT) scan or etc. obtained within 24 months prior to the Screening Visit. Subjects who have any observations of dementia other than Alzheimer's type after the last image diagnosis should be reconfirmed.

•Age 50 years

•Written informed consent is to have been obtained from the subject (if possible) or from the subject's legal guardian or other representative

Exclusion criteria

•Subjects with dementia other than Alzheimer's type

•Subjects with significant neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, a history of head injury with loss of consciousness, or a history of brain surgery followed by persistent deficits

•Subjects with allergy to donepezil hydrochloride or piperidine derivatives

•Subjects with a cause of Alzheimer's disease (AD) which is supported by any laboratory tests such as Vitamin B12, folate levels, triiodothyronine, free triiodothyronine, thyroxine, thyroid stimulating hormone (TSH) or serologic test for syphilis

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.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3

Time frame:Visit 2 [Day1] and Visit 3 [Day 15]

concentration, descriptive

Primary/registry result

Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3

Time frame:Visit 2 [Day1] and Visit 3 [Day 15]

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
E2020 SR 23 mgVisit 2n=22 Participants	126.503	31.27
Visit 3n=22 Participants	127.335	40.654
E2020 10 mgVisit 2n=23 Participants	97.006	32.934
Visit 3n=23 Participants	66.081	24

Secondary/protocol endpoint

Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status

Time frame:Visit 2 [Day1] and Visit 3 [Day 15]

concentration, descriptive

Secondary/registry result

Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status

Time frame:Visit 2 [Day1] and Visit 3 [Day 15]

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
E2020 SR 23 mgVisit 2 EM [IR: n=16, SR: n=17]n=22 Participants	117.999	28.898
Visit 2 IM [IR: n=5, SR: n=4]n=22 Participants	161.363	18.761
Visit 3 EM [IR: n=16, SR: n=15]n=22 Participants	116.771	31.663
Visit 2 IM [IR: n=5, SR: n=3]n=22 Participants	182.953	48.422
E2020 10 mg (EM)Visit 2 EM [IR: n=16, SR: n=17]n=23 Participants	98.117	32.323
Visit 2 IM [IR: n=5, SR: n=4]n=23 Participants	104.294	23.962
Visit 3 EM [IR: n=16, SR: n=15]n=23 Participants	63.896	20.662
Visit 2 IM [IR: n=5, SR: n=3]n=23 Participants	79.802	24.984

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.