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.

Lead sponsor

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

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

974

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 IDCR003145

NCT IDNCT00236574

Timeline

Milestones

Study start2001-05 (month precision)

Study completion2003-11actual (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 less than or equal to 10 on New York University paragraph recall test

•Sufficient visual, hearing and communication capabilities and willingness 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

•Contraindications for magnetic resonance imaging, for example, presence of pacemaker or presence of metal in high risk areas

•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 of metastatic cerebral neoplasia

•Significant endocrine or metabolic disease

•Mental retardation

•Women who are pregnant, nursing, or lacking 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

Executive function / language

Global cognition

1 endpoint

Primary/protocol endpoint

Memory and cognition (ADAS-cog/MCI and CDR-SB scores) at 12 months and Global functional skills and the overall severity of dementia (the CDR-SB and the overall CDR) at 24 months.

ADAS-Cog

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Brain atrophy assessed by MRI, Digit Symbol Coding, Alzheimer's Disease Cooperative Study-ADL scale(MCI version) at 24 months. Safety evaluations (adverse event reports, vital signs, laboratory tests, physical examination, electrocardiograms) throughout.

event count, event

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.