- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236431
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an international, multicenter, double-blind, randomized, placebo-controlled trial.
Patients with mild cognitive impairment (MCI) who are clinically at risk for development of Alzheimer's disease will be treated for 24 months with either placebo or galantamine hydrobromide.
Memory and overall clinical improvement will be evaluated using the Alzheimer's Disease Assessment Scale with cognitive subscale adapted to MCI (ADAS-cog/MCI) and the Clinical Dementia Rating Sum of the Boxes (CDR-SB).
Overall functional skills and the severity of dementia will be assessed with the Clinical Dementia Rating Sum of the Boxes (CDR-SB) and the overall Clinical Dementia Rating (CDR) score.
Additional assessments include the Digit Symbol Substitution Test (DSST) to measure attention.
Safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination, and electrocardiogram.
The study hypothesis is that treatment with galantamine will be well tolerated and, compared with placebo, will significantly improve the signs and symptoms associated with mild cognitive impairment in patients who are considered likely to develop Alzheimer's disease.
Galantamine hydrobromide immediate-release tablets (4, 8, or 12 milligrams), taken by mouth 2 times daily: 8mg/day for 4 weeks, 16mg/day for 4 weeks, then increased to 24mg/day for the remainder of the 24-month trial.
Doses may be reduced at investigator's discretion after 12 weeks.
Study Type
Interventional
Enrollment (Actual)
1063
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical decline of cognitive ability consistent with mild cognitive impairment
- Delayed recall score <= 10 on a New York University paragraph recall test
- Sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function
- Have a consistent informant to accompany them on scheduled visits
- Be able to read, write and fully understand the language of the cognitive scales used in the study
Exclusion Criteria:
- Neurodegenerative disorders such as Parkinson's disease
- Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary or metastatic cerebral neoplasia
- Epilepsy
- Significant psychiatric disease
- Peptic ulcer disease
- Clinically significant heart, lung, liver or kidney diseases
- Pregnant or nursing women or those 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 Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Memory and cognition (ADAS-COG/MCI and CDR-SB scores), global functional skills and overall severity of dementia (the CDR-SB and the overall Clinical Dementia Rating) measured at 12 and 24 months.
|
Secondary Outcome Measures
Outcome Measure |
---|
Digit Symbol Coding and Alzheimer's Disease Cooperative Study-ADL scale (MCI version) at 12 and 24 months. Safety assessment (reports of adverse events, laboratory values, results of physical examinations, and electrocardiograms) throughout the study.
|
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
May 1, 2001
Study Completion (Actual)
December 1, 2003
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- 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
- CR002014
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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