Clinical trial NCT00561392: Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease
Official title: A 24-week, Multi-center, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Rivastigmine
Patch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 208
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of 10 cm\^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm\^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age
* Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria
* MMSE (Mini-Mental State Examination) score of \> 10 and \< 26
* Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)
* Patients who failed to benefit from previous cholinesterase inhibitor treatment

Exclusion Criteria:

* Patients not treated according to the product monograph for rivastigmine capsules
* patients involved in a clinical trial
* Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)

Other protocol-defined exclusion criteria applied to the study.

Primary outcomes:
measure: Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study
timeFrame: Baseline to Week 24
measure: Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study
timeFrame: Baseline to Week 24
measure: Percentage of Participants Who Were Compliant to the 10 cm^2 Patch
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline in the Trail-making Test Part A Score at Week 24
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
timeFrame: Baseline t0 Week 24
measure: Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Articus K, Baier M, Tracik F, Kuhn F, Preuss UW, Kurz A. A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease. Int J Clin Pract. 2011 Jul;65(7):790-6. doi: 10.1111/j.1742-1241.2011.02713.x. Epub 2011 Jun 6.