Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00506415

Purpose

The purpose of this study is to support the optimal use of rivastigmine patch in long-term treatment of AD in patients demonstrating cognitive decline at the target maintenance dose of rivastigmine patch.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Rivastigmine transdermal patch	Phase III

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm2 Patch in Patients With Alzheimer's Disease Showing Cognitive Decline During an Initial Open-Label Treatment Phase

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from randomization baseline to Week 48 in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Secondary Outcome Measures:

Change from double-blind randomization baseline to Week 48 in instrumental activities of daily living as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) instrumental activities subscale
Time to functional decline assessed by the ADCS-ADL instrumental activities subscale over the 48-week Double-blind Treatment Phase
Change from double-blind randomization baseline to Week 48 in attention and executive function as assessed by the Trail Making Test Parts A and B
Change from double-blind randomization baseline to Week 48 in neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory (NPI).
Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study

Estimated Enrollment:	1200
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2010

Arms	Assigned Interventions
1: Active Comparator comparison of two doses	Drug: Rivastigmine transdermal patch
2: Active Comparator comparison of two doses	Drug: Rivastigmine transdermal patch

Eligibility

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

Criteria

Inclusion Criteria:

male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimer's Disease
baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive
a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments

Exclusion Criteria:

presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
any medical or neurological condition other than AD that could explain the patient's dementia,
a diagnosis of probable or possible vascular dementia,
a current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication
a history or current diagnosis of cerebrovascular disease (e.g. stroke)
a current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506415

Contacts

Contact: Novartis

+1-862-778-8300

Show 152 Study Locations

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CENA713D2340
Study First Received:	July 20, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00506415
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices (BfArM); France: Agence française de sécurité sanitaire des produits de santé (Afssaps); Italy: Agenzia Italiana del Farmaco (AIFA); Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS); Canada: Therapeutic Products Directorate (TPD); Switzerland: Swissmedic; United States: Food and Drug Administration

Keywords provided by Novartis:

Alzheimer Disease
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 January 16, 2009