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 (EXTRA)

This study is ongoing, but not recruiting participants.

First Received: February 14, 2008 Last Updated: August 5, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00622713

Purpose

This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 (MMSE 10-26)

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 treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population)

Secondary Outcome Measures:

Mini-Mental State Examination score at baseline, week 8, 24 and premature discontinuation
Clinical Global Impression of Change (week 8, 24 and premature discontinuation)
4 scores from the Activities of Daily Living (budget, transport, drug management, phone) at baseline, week 8 and week 24 or at premature discontinuation
At any time : Adverse events, vital signs, physical examination

Estimated Enrollment:	300
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: Rivastigmine transdermal patch

Eligibility

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

Criteria

Inclusion Criteria:

Males, and females of at least 50 years old with a primary caregiver
Probable Alzheimer's disease
Mini-Mental State Examination score of ≥ 10 and ≤ 26
Patients initiating therapy for the first time with a ChE inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday

Exclusion Criteria:

Patients not treated according to the product monograph for capsules
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)
History of allergy to topical products containing any of the constituents of the patches

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622713

Locations

France
Novartis Investigative Site
Rueil-Malmaison, France

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharma S.A.S.

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CENA713DFRO8, N° EudraCT : 2007-003405-27
Study First Received:	February 14, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00622713 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Alzheimer's disease
cholinesterase inhibitor
rivastigmine

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 27, 2009