- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00814801
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
March 31, 2014 updated by: Janssen Pharmaceutical K.K.
Placebo-controlled Confirmatory Study of Galantamine (R113675) for Alzheimer's Type Dementia
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day [mg/day]) in patients with Alzheimer's disease.
The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day.
For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day.
The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J).
Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings.
The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease.
Study drug taken orally twice a day.
Study Type
Interventional
Enrollment (Actual)
580
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
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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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
- Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
- Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period
Exclusion Criteria:
- Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
- Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
- Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
- Patients with clinically significant cardiovascular disease
- Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Form= tablet, route= oral use.
Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks.
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Experimental: Galantamine 16 mg/day
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Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use.
Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks.
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Experimental: Galantamine 24 mg/day
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Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use.
Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
Time Frame: Baseline and 24 weeks
|
ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS).
This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior.
The minimum score is zero (0) and means well cognitive function.
The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.
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Baseline and 24 weeks
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Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)
Time Frame: 24 weeks
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CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus).
It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from "markedly improved" to "markedly worse".
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Disability Assessment for Dementia (DAD)
Time Frame: Baseline and 24 weeks
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Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A.
A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100.
Items rated as Not Applicable (N/A) are not considered for the total score.
The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL).
Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
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Baseline and 24 weeks
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Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)
Time Frame: Baseline and 24 weeks
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Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms.
This four-point scale varies from 0 (=none) to 3 (= serious).
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Baseline and 24 weeks
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Change From Baseline in the Mental Function Impairment Scale (MENFIS)
Time Frame: Baseline and 24 weeks
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MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment.
This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment).
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Baseline and 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
December 24, 2008
First Submitted That Met QC Criteria
December 24, 2008
First Posted (Estimate)
December 25, 2008
Study Record Updates
Last Update Posted (Estimate)
April 17, 2014
Last Update Submitted That Met QC Criteria
March 31, 2014
Last Verified
March 1, 2014
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
- Alzheimer Disease
- 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
- CR010297
- GAL-JPN-5 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
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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