A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease (BETTER)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Rivastigmine transdermal
Sponsored by
About this trial
This is an interventional other trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Rivastigmine transdermal, caregiver preference
Eligibility Criteria
Inclusion Criteria:
- Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
- MMSE score of >10 and <26.
- Patients who were under ChE inhibitor treatment and experienced adverse events.
- Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.
Exclusion Criteria:
- Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
- Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
- History of allergy to topical products containing any of the constitution of the patches.
- Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
- Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
- Patients with body weight less than 40 kg.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigational Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Rivastigmine transdermal
Arm Description
Outcomes
Primary Outcome Measures
Caregiver questionnaire
Secondary Outcome Measures
Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)
Full Information
NCT ID
NCT01047579
First Posted
January 12, 2010
Last Updated
February 22, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01047579
Brief Title
A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
Acronym
BETTER
Official Title
A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.
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, Rivastigmine transdermal, caregiver preference
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivastigmine transdermal
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Rivastigmine transdermal
Primary Outcome Measure Information:
Title
Caregiver questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)
Time Frame
every visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
MMSE score of >10 and <26.
Patients who were under ChE inhibitor treatment and experienced adverse events.
Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.
Exclusion Criteria:
Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
History of allergy to topical products containing any of the constitution of the patches.
Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
Patients with body weight less than 40 kg.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ashkelon
Country
Israel
Facility Name
Novartis Investigational Site
City
Haifa
Country
Israel
Facility Name
Novartis Investigative Site
City
Holon
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
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