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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00216593
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 21, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Drug: galantamine hydrobromide Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : March 2008

Primary Outcome Measures :
  1. 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 :
  1. 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.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00216593

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00216593     History of Changes
Other Study ID Numbers: CR003940
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: April 2010

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
cognition function
Alzheimer disease
behavioral symptoms
galantamine hydrobromide

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents