Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Cholinesterase Inhibitors; 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 = 23

• Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit

• Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:

• Inadequate compliance with the ChE inhibitors at screening and baseline

• Presence of caregiver's burden for administering drugs orally at screening and baseline

• Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline

• Patients with swallowing difficulties at screening and baseline

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