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

Phase 3

Completed

• Conditions: Dementia; Alzheimer Disease

• Registration Number: NCT00216593
• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium

Brief Summary

The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.

Detailed Description

This is a multicenter, 1-year study that includes a randomized, 6-month, double-blind, placebo-controlled phase and a 6-month open-label extension of galantamine hydrobromide treatment in subjects with severe Alzheimer's disease. The open-label extension is optional for al patients. Patients eligible for the study will be randomized to treatment with either galantamine hydrobromide or placebo over 6 months for the first phase of the study. The principal measures include the results of the Severe Impairment Battery and the Minimum Data Set-Activities of Daily Living tests, to assess aspects of cognition and behavior, and impact on the patient's ability to perform normal daily activities. Additional evaluations include the Neuro-Psychiatric Inventory-Nursing Home Version measure and 2 subscales of the Minimum Data Set tests to further assess patients behavior, social and physical functioning, the level of caregiver support needed, and impact to the patient's caregiver; the Mini-Mental State Examination, to assess cognitive abilities; and external health-and social-service use. Safety and tolerability will be evaluated on the basis of adverse event reports, physical examination, electrocardiograms, vital signs, and laboratory parameters. The study hypothesis is that treatment with galantamine, compared with placebo, will significantly improve cognition and ability to function in patients with severe Alzheimer's disease, and is generally well-tolerated. Galantamine hydrobromide tablets taken by mouth two times daily: 4 weeks at 8 milligrams (mg)/day, 4 weeks at 16 mg/day, increased to 24 mg/day for the remainder of the 6 months. Dose may be reduced at investigator's discretion. Galatamine hydrobromide for additional 6 months in open-label phase.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2007-09
• Study Completion: 2008-03
• Status Verified: 2010-04
• Disposition First Submitted: 2011-06-07
• Disposition First Submitted QC: 2011-06-07
• Last Update Submitted: 2011-06-07
• Disposition First Posted: 2011-06-21
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.