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CompletedPhase 3

A Placebo-controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia

A Randomized 26-Week, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

254

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•Vascular dementia

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR002011
NCT IDNCT00035191

Timeline

Milestones

Study start2001-10 (month precision)
Study first posted2002-05-03estimated
Study completion2003-09actual (month precision)
Last update posted2011-06-08estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with vascular dementia per NINDS-AIREN criteria
•Radiologic evidence of VaD on MRI
•Clinical evidence of VaD (ie focal signs)
•Onset of dementia between ages 40 and 90 years
•Ability to read, write, communicate, and understand cognitive testing instructions
•No uncontrolled medical conditions

Exclusion criteria

•Presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation)
•Current significant cardiovascular disease that could limit the patient's ability to complete the study
•Major psychiatric diseases
•Peptic ulcer or significant urine outflow obstructions
•Seizures
•Other serious diseases
•History of drug or alcohol abuse within the past year

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.

Coverage by outcome category

Global cognition
1
Function / daily living
1

Global cognition

1 endpoint
Primary/protocol endpoint

Change from baseline to week 26 in Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-cog)

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) score and ADCS-ADL Inventory; neuropsychiatric inventory (NPI); in English-speaking countries only, the EXIT-25 scale.

ADCS-Activities of Daily Living (ADCS-ADL)

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.