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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)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00622713
First received: February 14, 2008
Last updated: June 27, 2011
Last verified: June 2011

February 14, 2008
June 27, 2011
January 2008
January 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Percentage of patients treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population)
Complete list of historical versions of study NCT00622713 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression of Change (CGI-C) by Physician [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    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".
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    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.
  • 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
Not Provided
Not Provided
 
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)
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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Rivastigmine transdermal patch
The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
Other Name: Exelon, Prometax
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
January 2009
January 2009   (final data collection date for primary outcome measure)

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.

Both
50 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00622713
CENA713DFR08, N° EudraCT : 2007-003405-27
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Pharma S.A.S. Novartis Pharmaceuticals
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP