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
1 other identifier
interventional
51
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2010
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 24, 2017
May 1, 2012
1.8 years
January 12, 2010
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caregiver questionnaire
12 weeks
Secondary Outcomes (1)
Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)
every visit
Study Arms (1)
Rivastigmine transdermal
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Novartis Investigative Site
Ashkelon, Israel
Novartis Investigational Site
Haifa, Israel
Novartis Investigative Site
Holon, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 13, 2010
Study Start
April 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 24, 2017
Record last verified: 2012-05