Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease. (CARE)
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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.
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 Outcome Measures :
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 ]
Patient compliance (drug accounting) [ Time Frame: During 24 weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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;
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