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CompletedPhase 3

Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

973

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-24

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR006037
NCT IDNCT00253214

Timeline

Milestones

Study start2001-03 (month precision)
Study completion2002-07actual (month precision)
Study first posted2005-11-15estimated
Last update posted2011-05-23estimated

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

•Outpatients with a diagnosis of mild-to-moderate 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 in residential homes for the elderly or day patients)
•have a Mini-Mental Status Examination (MMSE) score of 10 - 24, and a score of at least 18 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog-11) with an onset between ages 40 and 90
•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
•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
•dementia caused by small strokes or cerebrovascular disease
•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 end of treatment for controlled release group 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, /10, /mem scores, NPI, and ADCS/ADL; safety and tolerability of controlled-release formulation; difference in effects between the controlled-release and immediate-release formulations

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.