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CompletedPhase 3

A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease

Efficacy, Tolerability and Safety of Galantamine in the Treatment of Alzheimer's Disease

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

653

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 IDCR006031

NCT IDNCT00253188

Timeline

Milestones

Study start1997-02 (month precision)

Study completion1998-12actual (month precision)

Study first posted2005-11-15estimated

Last update posted2011-05-18estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living independently in residential homes for the elderly or day patients)

•have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination (MMSE) score of 11 - 24 and a score of at least 12 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog)

•history of at least a 6 months of gradual and progressive cognitive decline

•have a consistent informant to accompany the patient on scheduled visits

Exclusion criteria

•Neurogenerative disorders such as Parkinson's disease

•dementia caused by small strokes or cerebrovascular disease

•cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation or a brain tumor

•having epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney, or lung disorders, or heart disease

•Females of child bearing potential without adequate contraception

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

Change from baseline to the end of treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in ADAS-cog/13 and DAD scores to the end of treatment; concentration of drug in blood; PGWB; Health/social care resource use; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations

ADAS-Cog

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.