- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261573
A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia
May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The Safety and Efficacy of Galantamine in the Treatment of Vascular and Mixed Dementia
The purpose of this study is to evaluate the safety and efficacy of galantamine (a drug for treating dementia) compared to placebo in the treatment of patients with dementia related to cerebrovascular disease (vascular dementia) or dementia related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This multicenter, double-blind, placebo-controlled study will evaluate the safety and effectiveness of galantamine in patients with dementia related to cerebrovascular disease or related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia).
All patients will initially receive placebo for a 1-month period and then will receive galantamine (starting at a low dose and gradually increasing over 5 weeks to 12 mg twice daily) or placebo for 6 months.
The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of Change - Plus Caregiver Input).
Additional measures of effectiveness include the change from baseline to the end of the treatment in the ADAS-cog/13 score (Alzheimer's Disease Assessment Scale: sum of 13 cognitive items), the Disability Assessment for Dementia (DAD) score, and the Neuropsychiatric Inventory (NPI)) score.
Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) will be performed throughout the study.
Patients who complete the double-blind portion of the study will have the opportunity to participate in a 6-month open-label extension study in which they will receive galantamine for an additional 6 months.
Effectiveness will be assessed after 6 weeks, 3 months and 6 months of open-label treatment.
Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed throughout the open-label portion of the study.
The study hypothesis is that galantamine will be effective in the treatment of patients with vascular or mixed dementia and will be well tolerated.
Double-blind: Galantamine 12 mg or placebo by mouth twice daily for 6 months, starting at a low dose and gradually increasing over 5 weeks to the final dose; Open-label: galantamine 12 mg by mouth twice daily, starting at a low dose and gradually increasing over 6 weeks to the final dose.
Study Type
Interventional
Enrollment (Actual)
593
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients with a diagnosis of vascular dementia according to the NINDS-AIREN International Workshop criteria or with a diagnosis of "mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NINCDS-ADRDA criteria
- mild-to-moderate dementia (score of 10 - 25 on the Mini Mental Status Exam (MMSE) and ADAS-cog score of at least 12)
- having the opportunity to perform activities of daily living (such as dressing, bathing, etc), including patients living independently in residential homes for the elderly
- had onset of disease between ages 40 - 90
- have a consistent informant to accompany them on scheduled visits
Exclusion Criteria:
- Neurogenerative disorders such as Parkinson's disease
- cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor
- having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
- history of epilepsy, convulsions, drug abuse or alcohol abuse
- females of child bearing potential without adequate contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline to end of double-blind treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
|
Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline to the end of double-blind treatment in ADAS-cog/13, NPI, and DAD scores; Change in ADAS scores from baseline to end of open-label treatment; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1998
Study Completion (Actual)
December 1, 2000
Study Registration Dates
First Submitted
December 2, 2005
First Submitted That Met QC Criteria
December 2, 2005
First Posted (Estimate)
December 5, 2005
Study Record Updates
Last Update Posted (Estimate)
May 18, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Alzheimer Disease
- Dementia, Vascular
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Parasympathomimetics
- Galantamine
Other Study ID Numbers
- CR006034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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