Skip to main content
Delfa

← Trials/Trial dossier/NCT02162251

Completed

Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

3,482

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Investigations on adverse events and adverse drug reactions

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 IDART07T
NCT IDNCT02162251

Timeline

Milestones

Study start2013-06-01actual
Study first posted2014-06-12estimated
Primary completion2015-05-01actual
Study completion2016-04-15actual
Last update posted2018-09-07actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice

Exclusion criteria

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

Endpoints (3)

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
2
Safety / tolerability / PK
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Severity of dementia based on the Functional Assessment Staging Test (FAST)

Time frame:Baseline, Month 3, Month 6, and Month 12

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and Month 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Investigations on adverse events and adverse drug reactions

Time frame:Up to 12 months

event count, event

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.