An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT00814801|
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : July 4, 2012
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Placebo Drug: Galantamine 16 mg/day Drug: Galantamine 24 mg/day||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||580 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Placebo-controlled Confirmatory Study of Galantamine (R113675) for Alzheimer's Type Dementia|
|Study Start Date :||February 2007|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
U.S. FDA Resources
|Placebo Comparator: Placebo||
Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks.
|Experimental: Galantamine 16 mg/day||
Drug: Galantamine 16 mg/day
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.
|Experimental: Galantamine 24 mg/day||
Drug: Galantamine 24 mg/day
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.
- 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.
- Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J) [ Time Frame: 24 weeks ]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".
- Change From Baseline in the Disability Assessment for Dementia (DAD) [ Time Frame: Baseline and 24 weeks ]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.
- Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) [ Time Frame: Baseline and 24 weeks ]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).
- Change From Baseline in the Mental Function Impairment Scale (MENFIS) [ Time Frame: Baseline and 24 weeks ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814801
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|