Skip to main content
Delfa

← Trials/Trial dossier/NCT00301574

CompletedPhase 3

An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease.

Placebo-Controlled, Double-Blind Study of Galantamine (R113675) in the Treatment of Alzheimer's Disease.

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

398

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-22

Primary endpoint

•The Alzheimer's Disease Assessment Scale - Japan cognitive subscale

Identifiers

Registered as

Org study IDCR003301
NCT IDNCT00301574

Timeline

Milestones

Study start2001-04 (month precision)
Study completion2004-02actual (month precision)
Study first posted2006-03-13estimated
Last update posted2011-05-17estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
•having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
•having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
•exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period

Exclusion criteria

•Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
•Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
•Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
•Patients with clinically significant cardiovascular disease
•Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism

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

Function / daily living
1
Other clinical outcomes
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from baseline to the end of the study in CIBIC plus-J subscales (Disability Assessment for Dementia [DAD], Behavioral Pathology in Alzheimer's Disease Rating Scale [Behave-AD], the Mental Function Impairment Scale [MENFIS ]).

change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Change from baseline to the end of the study in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J)

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.