Official Title: “A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm2 Patch in Patients With Alzheimer's Disease Showing Cognitive Decline During an Initial Open-Label Treatment Phase”

The purpose of this study is to support the optimal use of rivastigmine patch in long-term treatment of AD in patients demonstrating cognitive decline at the target maintenance dose of rivastigmine patch.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2011

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine transdermal patch

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Experimental: 2

Primary Measures

• Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
  • Time Frame: From randomization baseline to Week 48
    Safety Issue?: No

Secondary Measures

• Change in instrumental activities of daily living as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) instrumental activities subscale
  • Time Frame: From double-blind randomization baseline to Week 48
    Safety Issue?: No
• Time to functional decline assessed by the ADCS-ADL instrumental activities subscale
  • Time Frame: Over the 48-week Double-blind Treatment Phase
    Safety Issue?: No
• Change in attention and executive function as assessed by the Trail Making Test Parts A and B
  • Time Frame: From double-blind randomization baseline to Week 48
    Safety Issue?: No
• Change in neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory (NPI).
  • Time Frame: From double-blind randomization baseline to Week 48
    Safety Issue?: No
• Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Time Frame: Throughout the study
    Safety Issue?: Yes

Inclusion Criteria:

• male or female patients between 50 and 85 years of age with a diagnosis of probable
• Alzheimer's Disease
• baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive
• a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments

Exclusion Criteria:

• presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
• any medical or neurological condition other than AD that could explain the patient's dementia,
• a diagnosis of probable or possible vascular dementia,
• a current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication
• a history or current diagnosis of cerebrovascular disease (e.g. stroke)
• a current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease)
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Overall Contact: Novartis +1-862-778-8300 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00506415

Study ID Number: CENA713D2340

ClinicalTrials.gov Identifier: NCT00506415

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency