An Open-Label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219232

Purpose

The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Rivastigmine Transdermal Patch	Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

Secondary Outcome Measures:

Change in cognition from baseline (week 24 of the double blind phase) at week 52
Clinical global impression of change from baseline at week 52
Change in activities of daily living from baseline at week 52
Change in behavioral symptoms from baseline at week 52
Change in executive function from baseline at week 52

Estimated Enrollment:	857
Study Start Date:	April 2004
Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219232

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CENA713D2320E1
Study First Received:	September 14, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00219232
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Alzheimer's disease
Dementia

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Rivastigmine
Mental Disorders
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 January 15, 2009