CompletedPhase 3

Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study

Treatment of Severe Alzheimer's Disease in a Residential Home, Nursing Home, or Geriatric Residential Setting: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Randomised, Doubleblind, Placebo-Controlled Study.

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

415

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Scores

Identifiers

Registered as

Org study IDCR003940

NCT IDNCT00216593

Timeline

Milestones

Study start2003-12 (month precision)

Study first posted2005-09-22estimated

Primary completion2007-09actual (month precision)

Study completion2008-03actual (month precision)

Last update posted2011-06-21estimated

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

•Diagnosis of Alzheimer's type dementia, rated as severe

•progressive worsening of memory and other cognitive functions

•brain imaging (CTor MRI scan) within last 3 years

•ability to be mobile (aided or unaided) with sufficient vision and hearing to comply with testing

Exclusion criteria

•Dementia caused by cerebrovascular disease

•disturbances of consciousness, delirium, psychosis

•severe aphasia

•or major sensorimotor impairment

•cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency, infections, primary of metastatic cerebral neoplasia, endocrine or metabolic disease or mental retardation, pregnant or nursing women or those without adequate contraception.

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

Disease progression

Global cognition

1 endpoint

Primary/protocol endpoint

Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.

change from baseline, improvement

Disease progression

1 endpoint

Secondary/protocol endpoint

Results from Neuro Psychiatric Inventory-nursing home version test. Safety assessments include reports of adverse events, physical exam, vital signs, electrocardiograms, and laboratory test results.

event count, event

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.