Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.

• 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 ≥ 10 and ≤ 20 at baseline

Exclusion Criteria:

• Any medical or neurological conditions other than AD that could explain the patient's dementia

• A current diagnosis of probable or possible vascular dementia

• A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)

• A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.

• Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.

• an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk

• Other protocol-defined inclusion/exclusion criteria may apply.