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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00622713 |
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Date of registration:
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14/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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) |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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228 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00622713 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Novartis Pharma S.A.S. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Drug: Rivastigmine transdermal patch
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score
[Time Frame: 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]
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Clinical Global Impression of Change (CGI-C) by Physician
[Time Frame: Baseline and week 24]
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Secondary ID(s)
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N° EudraCT : 2007-003405-27
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CENA713DFR08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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