Completed

A Study of the Safety and Effectiveness of Galantamine Hydrobromide in Patients With Alzheimer's Disease

Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients With Mild to Moderate Dementia of the Alzheimer Type

Lead sponsor

Janssen Cilag Pharmaceutica S.A.C.I., Greece

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

344

actual

Study population

Alzheimer’s disease

Key I/E criterion

Primary endpoints

•Mini-Mental State Examination (MMSE)•Changes from baseline in Disability Assessment for Dementia (DAD) scale scores•Neuropsychiatric Inventory (NPI)

Identifiers

Registered as

Secondary ID57504DEM4001Janssen Cilag Pharmaceutica S.A.C.I., Greece

Org study IDCR003559

NCT IDNCT00297362

Timeline

Milestones

Study start2004-06 (month precision)

Study completion2005-10actual (month precision)

Study first posted2006-02-28estimated

Last update posted2012-03-26estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with a score of 10-26 on the Mini Mental Status Exam

•Patients who have not yet received treatment for their Alzheimer's disease with a medication similar to galantamine or patients who have been treated with as medication similar to galantamine hydrobromide and who have discontinued that medication due to lack of effectiveness or poor tolerability (adverse events)

Exclusion criteria

•Patients with severely decreased liver or kidney function

•Patients with a digestive system or urinary blockage who are recovering from digestive system or urinary bladder surgery

•Patients with clinically significant unstable or uncontrolled hormonal or mental disease

•Patients who are unable to take the medication either alone or with help from another person who is available during the entire study period

Endpoints (8)

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

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

Function / daily living

Other clinical outcomes

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

Changes from baseline in Mini-Mental State Examination (MMSE) scale scores

Time frame:Baseline to 6 months

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint

Primary/protocol endpoint

Changes from baseline in Disability Assessment for Dementia (DAD) scale scores

Time frame:Baseline to 6 months

descriptive

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

event count, event

Primary/protocol endpoint

Changes from baseline in Cornell Scale

Time frame:Baseline to 6 months

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of patients with Adverse Events as Measure of Safety and Tolerability

Time frame:6 months

event count, event

Secondary/protocol endpoint

Number of patients whose vital signs fell outside the normal ranges

Time frame:6 months

event count, event

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Changes from baseline in Clinical Global Impression (CGI) scale scores

Time frame:Baseline to 6 months

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Number of patients whose laboratory test results fell outside the normal ranges

Time frame:6 months

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.