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CompletedPhase 3

A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease

A Randomized, Double Blind, Active Control, Flexible Dose, Multicenter Study to Evaluate Galantamine HBr in the Treatment of Alzheimer's Disease:Safety and Effectiveness of an Immediate-release Table Formulation.

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

215

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR005803
NCT IDNCT00645190

Timeline

Milestones

Study start2004-03 (month precision)
Study completion2005-02actual (month precision)
Study first posted2008-03-27estimated
Last update posted2011-05-19estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Out-patients diagnosed with mild to moderate probable AD. The diagnosis should have been established in accordance with the classification for probable AD of NINCDS-ADRDA
•MMSE score of 10-24 (inclusive) at screening
•Patients who lived with or had regular daily visits from a responsible caregiver
•.Has signed the informed consent form by subject and assent form by care-giver

Exclusion criteria

•Patients with neurodegenerative disorders such as Parkinson's disease
•Patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection
•Has evidence of multi-infarct dementia or clinically active cerebrovascular disease.

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
Other (unclassified)
1

Global cognition

1 endpoint
Primary/protocol endpoint

Primary endpoint (ADAS-cog/11) decreased 5.4 ± 6.4 and 4 .0 ± 7.3 in galantamine and Donepezil group respectively after 16-week treatment from baseline of 22.5 ± 9.3 and 23.3 ± 9.7 respectively, showing the non-inferiority in term of efficacy.

ADAS-Cog

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Secondary endpoint is responder rate. It showed 78% responder rate in galantamine group and 58% responder rate in Donepezil group after 16 weeks.

threshold achievement, 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.