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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
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 12, 2010
Last Updated
February 22, 2017
Sponsor
Novartis Pharmaceuticals
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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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