CompletedPhase 4

Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Lead sponsor

Janssen Pharmaceutical K.K.

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

102

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-22

Primary endpoint

•Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J 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 IDCR018649

Secondary IDJNS023-JPN-02Janssen Pharmaceutical K. K., Japan

NCT IDNCT01478633

Timeline

Milestones

Study start2011-09 (month precision)

Study first posted2011-11-23estimated

Primary completion2013-06actual (month precision)

Study completion2013-06actual (month precision)

Last update posted2014-03-26estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group

•Have an MMSE score of 10 to 22 inclusive at screening

•Have taken donepezil stably at 5 mg/day for more than 6 months before screening

•Have progression (worsening) of impaired cognitive function 6 months or longer before screening

•Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening

•Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion criteria

•Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type

•Has suspected impaired cognitive function due to a variety of causes

•Has significant health disorders or diseases according to the investigators' detailed criteria

•Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study

•Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study

•Has a history of severe drug allergy or severe drug hypersensitivity

•Has a history of drug or alcohol abuse

•Used another investigational drug within 90 days of screening

•Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening

•Is considered as ineligible by the investigator

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

Memory

Other clinical outcomes

Other (unclassified)

Memory

1 endpoint

Primary/protocol endpoint

The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24

Time frame:at Week 24

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

The Clinical Global Impression of Change (CGI-C) at Week 24

Time frame:at Week 24

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Proportion of Responders at Week 24

Time frame:at Week 24

threshold achievement, improvement

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.