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CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment

A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

1,063

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Age ≥50

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR002014
NCT IDNCT00236431

Timeline

Milestones

Study start2001-05 (month precision)
Study completion2003-12actual (month precision)
Study first posted2005-10-12estimated
Last update posted2011-06-08estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Clinical decline of cognitive ability consistent with mild cognitive impairment
•Delayed recall score <= 10 on a New York University paragraph recall test
•Sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function
•Have a consistent informant to accompany them on scheduled visits
•Be able to read, write and fully understand the language of the cognitive scales used in the study

Exclusion criteria

•Neurodegenerative disorders such as Parkinson's disease
•Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary or metastatic cerebral neoplasia
•Epilepsy
•Significant psychiatric disease
•Peptic ulcer disease
•Clinically significant heart, lung, liver or kidney diseases
•Pregnant or nursing women or those 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.

Coverage by outcome category

Global cognition
1
Executive function / language
1

Global cognition

1 endpoint
Primary/protocol endpoint

Memory and cognition (ADAS-COG/MCI and CDR-SB scores), global functional skills and overall severity of dementia (the CDR-SB and the overall Clinical Dementia Rating) measured at 12 and 24 months.

ADAS-Cog

descriptive

Executive function / language

1 endpoint
Secondary/protocol endpoint

Digit Symbol Coding and Alzheimer's Disease Cooperative Study-ADL scale (MCI version) at 12 and 24 months. Safety assessment (reports of adverse events, laboratory values, results of physical examinations, and electrocardiograms) throughout the study.

event count, event

Publications (1)

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.