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CompletedPhase 3

A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease

Long Term Treatment With Galantamine In Dementia

Lead sponsor

Janssen-Cilag S.p.A.

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

254

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 11-24

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR004996

NCT IDNCT00216502

Timeline

Milestones

Study start2001-08 (month precision)

Study first posted2005-09-22estimated

Study completion2005-11actual (month precision)

Last update posted2011-01-24estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable Alzheimer's disease according to accepted medical standards

•Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal

•Patients and their caregivers must have signed informed consent forms

Exclusion criteria

•Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency

•Patients with previous severe head injury or blood clot in the brain

•Patients who are hospitalized, living in nursing homes or residential care facilities

•Patients with brain infections such as abscess, meningitis, encephalitis

•Patients with a history of drug or alcohol abuse

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.

Global cognition

2 endpoints

Primary/protocol endpoint

Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points

ADAS-Cog

time to event, event

Secondary/protocol endpoint

Change in ADAS-cog, CIBIC-plus and DAD scores over time; Safety parameters assessed by adverse events; laboratory tests, vital signs, weight and ECGs.

ADAS-Cog

change from baseline, 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.