Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to investigate the 5cm^2 and 10cm^2 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). A 52-week extension phase evaluated the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable Alzheimer's Disease (AD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Rivastigmine

Criteria

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

Extension Phase Eligibility Criteria

Inclusion Criteria:

• Patients who have completed the Double-blind Treatment Phase on study medication

Exclusion Criteria

• Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase