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

NCT ID: NCT01399125

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-05-31

Brief 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).

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rivastigmine patch

Once-daily target patch size 10 cm²

Group Type: EXPERIMENTAL

Rivastigmine Patch

Intervention Type: DRUG

Once-daily target patch size 10 cm²

Placebo to Rivastigmine capsules

Intervention Type: DRUG

matching Placebo to Rivastigmine capsules

Rivastigmine capsules

Twice-daily target dose of 6 mg oral capsule

Group Type: ACTIVE_COMPARATOR

Rivastigmine Capsules

Intervention Type: DRUG

Twice-daily target dose of 6 mg oral capsule

Placebo to Rivastigmine patch

Intervention Type: DRUG

Matching placebo to Rivastigmine patch

Interventions

Rivastigmine Patch

Once-daily target patch size 10 cm²

Intervention Type: DRUG

Rivastigmine Capsules

Twice-daily target dose of 6 mg oral capsule

Intervention Type: DRUG

Placebo to Rivastigmine patch

Matching placebo to Rivastigmine patch

Intervention Type: DRUG

Placebo to Rivastigmine capsules

matching Placebo to Rivastigmine capsules

Intervention Type: DRUG

Other Intervention Names

ENA713, Exelon; ENA713, Exelon; placebo; placebo

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Fuzhou, Fujian, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Suzhou, Jiangsu, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Shanghai, Shanghai Municipality, China

Novartis Investigative Site

Xi’an, Shanxi, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Beijing, , China

Novartis Investigative Site

Beijing, , China

Novartis Investigative Site

Shanghai, , China

Novartis Investigative Site

Shanghai, , China

Novartis Investigative Site

Shanghai, , China

Novartis Investigative Site

Shanghai, , China

Countries

China

Other Identifiers

CENA713D2344

Identifier Type: -

Identifier Source: org_study_id