To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
216
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.
-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
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.
Time frame: Up to 24 weeks
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
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.
Time frame: Baseline, 8,16, and 24 weeks
Change From Baseline in Mini-Mental State Examination (MMSE)
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.
Time frame: Baseline and 24 weeks
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
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.
Time frame: 4, 8, 12,16, 20 and 24 weeks
The Percentage of Treatment Retention.
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
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Novartis Investigative Site
Anjo, Aichi-ken, Japan
Novartis Investigative Site
Ōbu, Aichi-ken, Japan
Novartis Investigative Site
Seto, Aichi-ken, Japan
Novartis Investigative Site
Toyoake, Aichi-ken, Japan
Novartis Investigative Site
Akita, Akita, Japan
Novartis Investigative Site
Chiba, Chiba, Japan
Novartis Investigative Site
Tōon, Ehime, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fujioka, Gunma, Japan
Novartis Investigative Site
Hiroshima, Hiroshima, Japan
...and 40 more locations
Time frame: Up to 24 weeks