Back to resultsAn Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rivastigmine Transdermal Patch
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Dementia
Eligibility Criteria
Inclusion Criteria: Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment
Secondary Outcome Measures
Change in cognition from baseline (week 24 of the double blind phase) at week 52
Clinical global impression of change from baseline at week 52
Change in activities of daily living from baseline at week 52
Change in behavioral symptoms from baseline at week 52
Change in executive function from baseline at week 52
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00219232
Brief Title
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Official Title
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
868 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rivastigmine Transdermal Patch
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment
Secondary Outcome Measure Information:
Title
Change in cognition from baseline (week 24 of the double blind phase) at week 52
Title
Clinical global impression of change from baseline at week 52
Title
Change in activities of daily living from baseline at week 52
Title
Change in behavioral symptoms from baseline at week 52
Title
Change in executive function from baseline at week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals Corporation
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19484917
Citation
Grossberg G, Sadowsky C, Frostl H, Frolich L, Nagel J, Tekin S, Zechner S, Ros J, Orgogozo JM. Safety and tolerability of the rivastigmine patch: results of a 28-week open-label extension. Alzheimer Dis Assoc Disord. 2009 Apr-Jun;23(2):158-64. doi: 10.1097/wad.0b013e31818b1c2c.
Results Reference
result
Learn more about this trial
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
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