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CompletedPhase 3

A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia

The Safety and Efficacy of Galantamine in the Treatment of Vascular and Mixed Dementia

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

593

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE ≥12

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR006034
NCT IDNCT00261573

Timeline

Milestones

Study start1998-12 (month precision)
Study completion2000-12actual (month precision)
Study first posted2005-12-05estimated
Last update posted2011-05-18estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Outpatients with a diagnosis of vascular dementia according to the NINDS-AIREN International Workshop criteria or with a diagnosis of "mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NINCDS-ADRDA criteria
•mild-to-moderate dementia (score of 10 - 25 on the Mini Mental Status Exam (MMSE) and ADAS-cog score of at least 12)
•having the opportunity to perform activities of daily living (such as dressing, bathing, etc), including patients living independently in residential homes for the elderly
•had onset of disease between ages 40 - 90
•have a consistent informant to accompany them on scheduled visits

Exclusion criteria

•Neurogenerative disorders such as Parkinson's disease
•cognitive impairment resulting from conditions such as 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 significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
•history of epilepsy, convulsions, drug abuse or alcohol abuse
•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 double-blind 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 to the end of double-blind treatment in ADAS-cog/13, NPI, and DAD scores; Change in ADAS scores from baseline to end of open-label treatment; 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.