Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
|ClinicalTrials.gov Identifier: NCT01614886|
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : May 12, 2015
Last Update Posted : August 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Active Comparator Drug: ENA713||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch (ENA713D/ONO-2540) in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-20)|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
U.S. FDA Resources
|Experimental: 1 step||
Drug: Active Comparator
1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.
|Active Comparator: 3 step||
-3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
- Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation [ Time Frame: Up to 24 weeks ]The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.
- Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) [ Time Frame: Baseline, 8,16, and 24 weeks ]The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.
- Change From Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline and 24 weeks ]The MMSE was used to measure severity of Alzheimer's disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.
- Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly [ Time Frame: 4, 8, 12,16, 20 and 24 weeks ]The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.
- The Percentage of Treatment Retention. [ Time Frame: Up to 24 weeks ]Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings - 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614886
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|