Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
- Registration Number
- NCT00731224
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Rivastigmine transdermal patch -
- Primary Outcome Measures
Name Time Method Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks. At week 24
- Secondary Outcome Measures
Name Time Method 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). At baseline, wk 12 and wk 24 Patient compliance (drug accounting) During 24 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇹🇷Uskudar / Istanbul, Turkey