A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease

Novartis

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo to Rivastigmine capsules; Drug: Rivastigmine Capsules; Drug: Placebo to Rivastigmine patch; Drug: Rivastigmine Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01399125

CENA713D2344

Details and patient eligibility

About

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).

Enrollment: 501 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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501 participants in 2 patient groups

Rivastigmine patch

Experimental group

Description:

Once-daily target patch size 10 cm²

Treatment:

Drug: Rivastigmine Patch

Drug: Placebo to Rivastigmine capsules

Rivastigmine capsules

Active Comparator group

Description:

Twice-daily target dose of 6 mg oral capsule

Treatment:

Drug: Placebo to Rivastigmine patch

Drug: Rivastigmine Capsules