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CompletedPhase 3

A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment

An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Galantamine HBr in the Treatment of Mild Cognitive Impairment

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

724

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•Age ≥50

Primary endpoint

•Adverse events

Identifiers

Registered as

Org study IDCR005947
NCT IDNCT00240695

Timeline

Milestones

Study start2003-05 (month precision)
Study completion2004-05actual (month precision)
Study first posted2005-10-18estimated
Last update posted2011-05-18estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Completed 24 months of double-blind treatment in 1 of 2 previous studies with galantamine without progressing to dementia (CDR< 1)
•Able to safely receive open-label galantamine in the opinion of the investigator and treatment is in the individual's best interest
•Regular (at least 3 days a week) visits from a person able to accompany patient to scheduled visits
•Enrolled within 7-30 days after the previous galantamine study

Exclusion criteria

•Individuals who converted to dementia (CDR > = 1) during 1 of the previous galantamine studies
•Prematurely discontinued 1 of the previous galantamine studies or completed 1 of the previous studies more than 30 days prior to this study
•Current clinically significant cardiovascular disease (including heart surgery, unstable angina, congestive heart failure, fibrillation, valve disease or uncontrolled high blood pressure)

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
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change in CDR, ADAS-Cog/MCI version, CDR-SB and SF-36 scores from baseline to end of treatment; resource use; time to conversion to dementia

ADAS-Cog

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations

event count, event

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.