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

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

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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

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). [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognitive and global outcome of the patients: Mini-Mental-State-Examination [ Time Frame: Screening, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Change [ Time Frame: after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
Trail Making Test A [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
Activities of Daily living [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
Safety/tolerability data (AEs and SAEs) [ Time Frame: Throughout the trial ] [ Designated as safety issue: Yes ]
Patient compliance with the patch (drug accounting) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Caregiver preference and satisfaction with the patch [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Caregiver burden (mini-Zarit score) [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Rivastigmine

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Locations

Germany
Novartis Investigative Site
Munich, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CENA713DDE15
Study First Received:	November 19, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00561392 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Alzheimer's Disease
Rivastigmine
Patch

Additional relevant MeSH terms:

Neurotransmitter Agents
Rivastigmine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009