Completed

An Observational Study of the Safety and Effectiveness of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period

An Observational Study of Clinical Outcomes and Safety Profile of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period

Lead sponsor

Janssen-Cilag Pty Ltd

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

Primary endpoint

•Investigate the change in cognitive functioning, clinical

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCR004816

NCT IDNCT00299676

Timeline

Milestones

Study start2005-05 (month precision)

Study first posted2006-03-07estimated

Primary completion2008-03actual (month precision)

Study completion2008-03actual (month precision)

Last update posted2014-05-23estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients prescribed with galantamine according to the approved New Zealand Data Sheet

•The clinical decision to prescribe Galantamine must have been made before and independently of the decision to enroll the patient in this observational study

•The patient should not have commenced Galantamine treatment before the baseline visit

•Patients must be currently living at home (i.e. not in permanent residential care)

•Availability of a supporter who has regular contact with the patient

Exclusion criteria

•Patients having known hypersensitivity to Galantamine

•Having severe liver impairment or severe kidney impairment

•Suffering from an uncontrolled medical condition other than dementia

•Being treated, or previously treated, with another cholinesterase inhibitor or other cholinomimetics (medications for treating Alzheimer's disease)

Endpoints (3)

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.

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting.

Time frame:Baseline, month 3, month 6, month 12 and month 18.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Development of information regarding treatment expectations that can be used for communicating with patients and supporters.

Time frame:Baseline, month 3, month 6, month 12 and month 18.

descriptive

Secondary/protocol endpoint/low confidence

Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers.

Time frame:Baseline, month 3, month 6, month 12 and month 18.

descriptive

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.