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CompletedPhase 2

A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

Lead sponsor

Eisai Limited

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 1-12•Study partner/caregiver required

Primary endpoints

•Primary Outcomes•CIBIC plus*, SIB**•(*for overall evalution of clinical symtoms)

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-J081-231

NCT IDNCT00165659

Timeline

Milestones

Study start2002-11 (month precision)

Primary completion2005-05actual (month precision)

Study first posted2005-09-14estimated

Last update posted2010-01-29estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Inclusion criteria

•Patients with diagnostics of Alzheimer's disease (AD) according to DSM-IV.

•Patients with modified Hachinski Ischemic scale score of ≦6.

•FAST score of ≧6 at baseline (4 weeks before starting study treatment).

•MMSE score between 1 and 12 at baseline (4 weeks before starting study treatment).

•Imaging diagnostics (CT, MRI, etc., within 24 months consistent with the diagnosis of AD without any other comorbid pathologies found. If a significant change in clinical status suggesting other types of dementia (except AD) is suspected between the final image diagnosis and the time of starting observation, the scan test should be repeated.

•Patients who can comply with the requirements on concomitant drugs/therapies from the baseline phase or before.

•Patients aged 50 years or older.

•Outpatients. Even in the case of an outpatient or a patient attending on the outpatient-visit basis from a nursing home facility, the caregiver must be a constant and reliable informant with minimum of 3 days per week direct contact with the patient (for at least 4 hours per day on waking hours). This contact is necessary to ensure accurate reporting of the patient's behavior and his/her ability to perform ADLs.

•Patients who are expected to complete all procedures scheduled during the Screening and Baseline visit and who have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the treatment schedule.

•Patients who can swallow tablets without pulverization.

•Patients who are ambulatory at least aided (walker) and have vision and hearing necessary for compliance with testing procedures (eyeglasses and/or hearing aid permissible).

•Patients whose representatives can sign the written informed consent

Exclusion criteria

•Patients with dementia other than AD.

1. Patient whose imaging test shows "circumscribed cerebral lesion or multiple infarcts" which is suspected to be the responsible cause of dementia (mixed-type dementia)

2. Patients with other types of dementia

•Patients with a current DSM-IV diagnosis of major depressive disorder or any current serious psychiatric diagnosis othe than AD.

•Patients without a reliable caregiver.

•Patients who are expected to enter a nursing home facility within 6 months after starting study treatment (excluding a transient entry).

•Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of study drugs (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or severe lactose intolerance).

•Patients with a known hypersensitivity to a component of donepezil hydrochloride preparation or piperidine derivatives.

•Patients complicated with a severe gastrointestinal, hepatic, renal, endocrine, or cardiovascular system disease (e.g., sick sinus syndrome, intraarterial and supraventricular conduction disorder, etc.).

•Patients with a history of severe bronchial asthma or obstructive pulmonary disease.

•Patients with a severe extrapyramidal disease (Parkinson's disease, Parkinson's syndrome, etc.).

•Patients with diabetes mellitus with uncontrolled blood glucose levels (HbAlc of ≧10%).

•Hypertension patients with uncontrolled blood pressure (diastolic blood pressure of ≧95 mmHg).

•Patients with uncontrolled thyroid dysfunction.

•Patients with a history of seizure or convulsion within the previous 3 months (obtaining informed consent).

•Patients with a known or suspected history of alcohoism or drug dependence within the recent 10 years.

•Patients with malignant tumors.

•Women of pregnant, possibly pregnant, or lactating.

•Patients who have participated in another clinical study within the recent 3 months (before giving consent).

•Any other patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Endpoints (8)

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

Other (unclassified)

Global cognition

Safety / tolerability / PK

Function / daily living

Global cognition

2 endpoints

Primary/protocol endpoint

CIBIC plus*, SIB**

descriptive

Primary/protocol endpoint

(**for cognitive function test)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Behave-AD, ADCS-ADL-sev

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Safety:

descriptive

Primary/protocol endpoint

Adverse event, adverse drug reaction, vital sign, clinical laboratory parameter, electrocardiogram

event count, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Primary Outcomes: Efficacy:

descriptive

Primary/protocol endpoint/low confidence

(*for overall evalution of clinical symtoms)

descriptive

Secondary/protocol endpoint/low confidence

Efficacy

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.