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OpenTrials
Completed

NCT Number: NCT00731224

Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, East Gosford, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine transdermal patch

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Patient compliance (drug accounting)

    Time frame: During 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Acronym: CARE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 8, 2008
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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