- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00622713
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA) (EXTRA)
June 27, 2011 updated by: Novartis
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)
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rueil-Malmaison, France
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males, and females of at least 50 years old with a primary caregiver
- Probable Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
- Patients initiating therapy for the first time with a Cholinesterase (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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
Time Frame: 24 weeks
|
The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.
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24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression of Change (CGI-C) by Physician
Time Frame: Baseline and week 24
|
The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition.
The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period.
The CGIC is rated on the following seven-point scale:"very much improved", "much improved", "slightly improved", "unchanged", "slightly worsened", "much worsened" and "very much worsened".
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Baseline and week 24
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Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score
Time Frame: Baseline to week 24
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The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget.
Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16.
A lower score indicates a more self-sufficient individual.
A positive change from baseline score indicates worsening.
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Baseline to week 24
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Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline to week 24
|
The MMSE is a brief, practical screening test for cognitive dysfunction.
The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function.
A positive change score indicates improvement from baseline.
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Baseline to week 24
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Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score
Time Frame: Baseline to week 24
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The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient.
The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often.
The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.
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Baseline to week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Novartis Pharma S.A.S., Novartis Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
January 1, 2009
Study Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
February 14, 2008
First Submitted That Met QC Criteria
February 22, 2008
First Posted (ESTIMATE)
February 25, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 26, 2011
Last Update Submitted That Met QC Criteria
June 27, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Cholinesterase Inhibitors
- Rivastigmine
Other Study ID Numbers
- CENA713DFR08
- N° EudraCT : 2007-003405-27
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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