Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease - Full Text View

Purpose

This study will evaluate the safety and efficacy of 10 cm2 Rivastigmine Patch in patients with Alzheimer Disease (MMSE 10-26). Primary objective is the percentage of patients who stay on the target size of 10 cm2 for at least 8 weeks. This proportion will then be compared to historic data with the percentage of patients who could reach Rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks, in previous Rivastigmine trials.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Rivastigmine	Phase IV

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title:	A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks).

Secondary Outcome Measures:

Cognitive and global outcome of the patients: Mini-Mental-State-Examination (Screening, after 4, 8 and 24 weeks)
Clinical Global Impression of Change (after 4, 8 and 24 weeks)
Trail Making Test A (Baseline, after 4, 8 and 24 weeks)
Activities of Daily living (Baseline, after 4, 8 and 24 weeks)
Safety/tolerability data (AEs and SAEs)
Patient compliance with the patch (drug accounting)
Caregiver preference and satisfaction with the patch
Caregiver burden (mini-Zarit score, Baseline, after 4, 8 and 24 weeks)

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
1: Experimental	Drug: Rivastigmine

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal) of at least 50 years of age;
Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSMIV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
MMSE (Mini Mental State Examination) score of > 10 and < 26;
Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both Rivastigmine and memantine are allowed);
Patients who failed to benefit from previous cholinesterase inhibitor treatment

Exclusion Criteria:

Patients not treated according to the product monograph for Rivastigmine capsules;
patients involved in a clinical trial;
Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application);

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561392

Contacts


Contact: Novartis	+41 61 324 1111

Locations


Germany
	Novartis Investigative Site	Recruiting
	Munich, Germany
	Contact +41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CENA713DDE15
First Received:	November 19, 2007
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00561392
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Alzheimer's Disease

Rivastigmine

Patch

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Rivastigmine

Arnold-Chiari Malformation

Mental Disorders

Arnold-Chiari malformation

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Enzyme Inhibitors

Cholinergic Agents

Neuroprotective Agents

Protective Agents

Pharmacologic Actions

Cholinesterase Inhibitors

Therapeutic Uses

Tauopathies

Central Nervous System Agents

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00561392