NCT00731224CompletedPhase 4
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: Rivastigmine transdermal patch (Drug)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Study Sites (1)
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