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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01399125
First received: July 19, 2011
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Drug: Rivastigmine Patch
Drug: Rivastigmine Capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (Mini-Mental State Examination (MMSE) 10-20)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline on cognition, assessed by the ADAS-Cog [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in global functioning, assessed by the ADCS-CGIC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in caregiver-based activities of daily living (ADL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in behavioral symptoms, assessed by the NPI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in global cognitive function, assessed by the MMSE [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Assess the safety and tolerability of Rivastigmine with respect to adverse events, serious adverse events, nausea and vomiting, application site reactions, changes in safety evaluations, such as vital signs, ECG and laboratory parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 501
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivastigmine Patch (target size 10 cm²) Drug: Rivastigmine Patch
Active Comparator: Rivastigmine capsules (target dose of 6.0 mg bid) Drug: Rivastigmine Capsules

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399125

Locations
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100191
Novartis Investigative Site
Beijing, Beijing, China, 100088
China, Fujian
Novartis Investigative Site
Fuzhou, Fujian, China
China, Guangdong
Novartis Investigative Site
Guang Zhou, Guangdong, China, 510260
Novartis Investigative Site
Guangzhou, Guangdong, China, 510180
China, Hubei
Novartis Investigative Site
Wuhan, Hubei, China, 430030
Novartis Investigative Site
Wuhan, Hubei, China, 430022
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Novartis Investigative Site
Suzhou, Jiangsu, China, 215004
China, Jilin
Novartis Investigative Site
Changchun, Jilin, China, 130021
China, Shanghai
Novartis Investigative Site
Shanghai, Shanghai, China, 200080
China, Shanxi
Novartis Investigative Site
Xi'an, Shanxi, China, 710032
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310009
China
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China, 100096
Novartis Investigative Site
Beijing, China, 100028
Novartis Investigative Site
Guang Zhou, China, 510010
Novartis Investigative Site
Shanghai, China, 200025
Novartis Investigative Site
Shanghai, China, 200003
Novartis Investigative Site
Shanghai, China, 200127
Novartis Investigative Site
Shanghai, China, 200040
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01399125     History of Changes
Other Study ID Numbers: CENA713D2344
Study First Received: July 19, 2011
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration
China: Ethics Committee
China: Food and Drug Administration

Keywords provided by Novartis:
Alzheimer's
Rivastigmine
Patch
Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014