Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

Phase 3

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: ENA713
Drug: Active Comparator

Registration Number: NCT01614886

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 216

Inclusion Criteria

A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
An MMSE score of ≥ 10 and ≤ 20 at baseline

Exclusion Criteria

Any medical or neurological conditions other than AD that could explain the patient's dementia
A current diagnosis of probable or possible vascular dementia
A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 step	ENA713	-
1 step	Active Comparator	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation	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.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Treatment Retention.	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
Change From Baseline in Mini-Mental State Examination (MMSE)	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.
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)	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.
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	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.