Clinical Trial: Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official 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 Alzhei
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 Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: 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 ]
Original Primary Outcome: 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.
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- 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
Information By: Novartis
Dates:
Date Received: August 5, 2008
Date Started: July 2008
Date Completion:
Last Updated: March 24, 2017
Last Verified: March 2017
