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

June 30, 2016 updated by: Novartis Pharmaceuticals

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Anjo-city, Aichi, Japan, 446-8510
        • Novartis Investigative Site
      • Obu-city, Aichi, Japan, 474-8511
        • Novartis Investigative Site
      • Seto-city, Aichi, Japan, 489-8642
        • Novartis Investigative Site
      • Toyoake-city, Aichi, Japan, 470-1168
        • Novartis Investigative Site
    • Akita
      • Akita-city, Akita, Japan, 010-0874
        • Novartis Investigative Site
    • Chiba
      • Chiba-city, Chiba, Japan, 260-8712
        • Novartis Investigative Site
    • Ehime
      • Toon-city, Ehime, Japan, 791-0295
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 814-0180
        • Novartis Investigative Site
    • Gumma
      • Fujioka-city, Gumma, Japan, 375-0017
        • Novartis Investigative Site
    • Hiroshima
      • Hiroshima-city, Hiroshima, Japan, 734-8530
        • Novartis Investigative Site
      • Miyoshi-city, Hiroshima, Japan, 728-0013
        • Novartis Investigative Site
    • Ibaraki
      • Kasama-city, Ibaraki, Japan, 309-1793
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura-city, Kanagawa, Japan, 247-8533
        • Novartis Investigative Site
      • Kawasaki-city, Kanagawa, Japan, 216-8511
        • Novartis Investigative Site
      • Kawasaki-city, Kanagawa, Japan, 212-0016
        • Novartis Investigative Site
      • Sagamihara-city, Kanagawa, Japan, 252-5188
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 241-0811
        • Novartis Investigative Site
    • Kochi
      • Kochi-city, Kochi, Japan, 780-0842
        • Novartis Investigative Site
      • Kochi-city, Kochi, Japan, 780-8037
        • Novartis Investigative Site
    • Kumamoto
      • Koshi-city, Kumamoto, Japan, 861-1116
        • Novartis Investigative Site
      • Kumamoto City, Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
      • Kumamoto-city, Kumamoto, Japan, 861-8002
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 600-8558
        • Novartis Investigative Site
      • Kyoto-city, Kyoto, Japan, 607-8411
        • Novartis Investigative Site
      • Kyoto-city, Kyoto, Japan, 616-8255
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 982-8523
        • Novartis Investigative Site
    • Miyazaki
      • Kitamorokata-gun, Miyazaki, Japan, 889-1911
        • Novartis Investigative Site
    • Nagano
      • Azumino-city, Nagano, Japan, 399-8204
        • Novartis Investigative Site
      • Matsumoto-city, Nagano, Japan, 399-8701
        • Novartis Investigative Site
    • Niigata
      • Nagaoka-city, Niigata, Japan, 940-2302
        • Novartis Investigative Site
    • Okayama
      • Kurashiki-city, Okayama, Japan, 710-0826
        • Novartis Investigative Site
      • Okayama-city, Okayama, Japan, 700-8607
        • Novartis Investigative Site
    • Osaka
      • Sakai-city, Osaka, Japan, 590-0018
        • Novartis Investigative Site
      • Suita-city, Osaka, Japan, 565-0871
        • Novartis Investigative Site
      • Suita-city, Osaka, Japan, 565-0874
        • Novartis Investigative Site
    • Saga
      • Kanzaki-gun, Saga, Japan, 842-0192
        • Novartis Investigative Site
    • Saitama
      • Kasukabe-city, Saitama, Japan, 344-0036
        • Novartis Investigative Site
      • Kawaguchi-city, Saitama, Japan, 333-0832
        • Novartis Investigative Site
      • Koshigaya-city, Saitama, Japan, 343-0032
        • Novartis Investigative Site
      • Saitama-city, Saitama, Japan, 338-0003
        • Novartis Investigative Site
    • Shizuoka
      • Shizuoka-city, Shizuoka, Japan, 420-8688
        • Novartis Investigative Site
      • Shizuoka-city, Shizuoka, Japan, 424-8636
        • Novartis Investigative Site
    • Tokushima
      • Tokushima-city, Tokushima, Japan, 770-8503
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 193-0998
        • Novartis Investigative Site
      • Koto-ku, Tokyo, Japan, 136-0075
        • Novartis Investigative Site
      • Musashino-city, Tokyo, Japan, 180-8610
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0016
        • Novartis Investigative Site
      • Tachikawa-city, Tokyo, Japan, 190-8531
        • Novartis Investigative Site
    • Yamaguchi
      • Shimonoseki-city, Yamaguchi, Japan, 752-8510
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: ENA713
-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8,16, and 24 weeks
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.
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
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.
4, 8, 12,16, 20 and 24 weeks
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
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713D1303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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