Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
|ClinicalTrials.gov Identifier: NCT01478633|
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Galantamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24)
- The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24 [ Time Frame: at Week 24 ]The ADAS-J cog scale assesses memory, language and behavior and is composed of 11 tasks: word recall, spoken language ability, auditory comprehension, word finding difficulty in spontaneous speech, following commands, object and finger naming, constructional praxis, ideational praxis, orientation, word recognition, and recalling test instructions. The perfect total score is 70 points, and as the score becomes higher, the degree of impairment becomes severer.
- The Clinical Global Impression of Change (CGI-C) at Week 24 [ Time Frame: at Week 24 ]CGI-C is employed to evaluate the patient's global clinical improvement according to the rater's impression from 1 (Very much improved) to 7 (Very much worse).
- Proportion of Responders at Week 24 [ Time Frame: at Week 24 ]Proportion of responders whose ADAS-J cog score at endpoint decreased from baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478633
|Kochi N/A, Japan|
|Saitama N/A, Japan|
|Study Director:||Janssen Pharmaceutical K. K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|