Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease. (CARE)

March 24, 2017 updated by: Novartis Pharmaceuticals

A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.

This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Phase 4

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

  • Australia
      • Nedlands, Australia, WA 6009
        • Novartis Investigative Site
    • New South Wales
      • East Gosford, New South Wales, Australia, 2250
        • Novartis Investigative Site
      • Gosford, New South Wales, Australia, 2250
        • Novartis Investigative Site
      • Hornsby, New South Wales, Australia, 2077
        • Novartis Investigative Site
      • Randwick, New South Wales, Australia, 2031
        • Novartis Investigative Site
    • Queensland
      • Chemside, Queensland, Australia, 4032
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
      • Woodville, South Australia, Australia, 5011
        • Novartis Investigative Site
    • Victoria
      • Ballarat, Victoria, Australia, 3353
        • Novartis Investigative Site
      • Fitzroy, Victoria, Australia, 3065
        • Novartis Investigative Site
      • Heidelberg, Victoria, Australia, 3081
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 143-729
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
    • Seongnam
      • Bundang, Seongnam, Korea, Republic of, 463-707
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Novartis Investigative Site
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Novartis Investigative Site
    • Perak
      • Ipoh, Perak, Malaysia, 30990
        • Novartis Investigative Site
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 50586
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
  • Turkey
      • Altunizade, Turkey, 34662
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Ankara, Turkey, 06500
        • Novartis Investigative Site
      • Antalya, Turkey, 07070
        • Novartis Investigative Site
      • Atakum / Samsun, Turkey, 55139
        • Novartis Investigative Site
      • Bursa, Turkey, 16059
        • Novartis Investigative Site
      • Emek / Ankara, Turkey, 06510
        • Novartis Investigative Site
      • Etlik / Ankara, Turkey, 06018
        • Novartis Investigative Site
      • Istanbul, Turkey, 34093
        • Novartis Investigative Site
      • Istanbul, Turkey, 34303
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Novartis Investigative Site
      • Konya, Turkey, 42080
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Novartis Investigative Site
      • Meselik / Eskisehir, Turkey, 26480
        • Novartis Investigative Site
      • Talas / Kayseri, Turkey, 38039
        • Novartis Investigative Site
      • Uskudar / Istanbul, Turkey, 34668
        • 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
  • MMSE score of ≥10 and ≤ 26;

Exclusion Criteria:

  • Bradycardia (beats per minute less than 50)
  • Body weight less than 40 kg;
  • Hypersensitivity to cholinesterase inhibitors.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Rivastigmine transdermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
Time Frame: At week 24
At week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).
Time Frame: At baseline, wk 12 and wk 24
At baseline, wk 12 and wk 24
Patient compliance (drug accounting)
Time Frame: During 24 weeks
During 24 weeks

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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, 2008

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (ESTIMATE)

August 8, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713DAU01

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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