Official Title: “A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Evaluation of the Efficacy, Safety, and Tolerability of the Once-Daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease (MMSE 10-20)”

The purpose of this study is to investigate the 5cm2 and 10cm2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE [Mini Mental State Examination]10-20)

Study Type: Interventional

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

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: rivastigmine transdermal patch
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Experimental: 2
• Experimental: 3

Primary Measures

• Change from baseline in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog)
  • Time Frame: after 24 weeks treatment
    Safety Issue?: No
• Change from baseline in the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J)
  • Time Frame: after 24 weeks treatment
    Safety Issue?: No

Secondary Measures

• Change from baseline in CIBIC plus-J score (Disability Assessment for Dementia [DAD], Behavioral Pathology in Alzheimer's Disease Rating Scale [Behave-AD], the Mental Function Impairment Scale [MENFIS ])
  • Time Frame: after 24 weeks of treatment
    Safety Issue?: No
• Change from baseline in MMSE
  • Time Frame: after 24 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
• A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
• An MMSE score of > or = 10 and < or = 20

Exclusion Criteria:

• A current DSM-IV diagnosis of major depression
• Taken rivastigmine in the past
• A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined inclusion/exclusion criteria may apply
• 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  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00423085

Study ID Number: CENA713D1301

ClinicalTrials.gov Identifier: NCT00423085

Health Authority: Japan: Ministry of Health, Labor and Welfare