A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine Patch; Rivastigmine Capsules; Placebo to Rivastigmine patch; Placebo to Rivastigmine capsules
Intervention description: Once-daily target patch size 10 cm²; Twice-daily target dose of 6 mg oral capsule; Matching placebo to Rivastigmine patch; matching Placebo to Rivastigmine capsules
Intervention MeSH terms: Rivastigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 501.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's; Rivastigmine; Patch; Dementia

Summary:

      The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon®
      patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory
      submission and registration of Exelon transdermal patch in China. The study is designed to
      confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus
      Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease
      Assessment Scale-Cognitive Subscale (ADAS-Cog).
    

Eligibility criteria:

        Inclusion criteria:

          -  have a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and
             Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria;

          -  have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria.

          -  have a brain scan (magnetic resonance imaging (MRI) or computed tomography (CT))
             consistent with the diagnosis of AD. The brain scan must have been performed within
             one year prior to randomization;

          -  have an MMSE score of ≥ 10 and ≤ 20;

          -  have sufficient education to have been able to read, write, and communicate
             effectively during the premorbid state;

          -  be residing with someone in the community throughout the study or, if living alone, in
             contact with the primary caregiver everyday;

        Exclusion criteria:

          -  have an advanced, severe, progressive, or unstable infectious, metabolic, immune,
             endocrinologic, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal,
             and/or urological condition that may interfere with efficacy and safety assessments or
             put the patient at special risk;

          -  have a history or current diagnosis of any medical or neurological condition other
             than AD that is identified as contributing cause of the patient's dementia;

          -  have a current diagnosis of probable or possible vascular dementia according to the
             National Institute of Neurological Disorders and Stroke and the Association
             Internationale pour la Recherche et l'Enseignement en Neurosciences criteria
             (NINDS-AIREN);

          -  have a score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);

          -  have a current DSM-IV diagnosis of major depression, unless, in the opinion of the
             investigator, is in remission for at least 12 weeks;

        Other protocol-defined inclusion/exclusion criteria may apply