A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
Information source: Novartis
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Rivastigmine transdermal (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: +41-61-324-1111
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.
Clinical Details
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 design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Caregiver questionnaire
Secondary outcome: Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, Phone: +41-61-324-1111
Novartis Investigative Site, Ashkelon, Israel; Recruiting
Novartis Investigational Site, Haifa, Israel; Recruiting
Novartis Investigative Site, Holon, Israel; Recruiting
Novartis Investigative Site, Ramat Gan, Israel; Recruiting
Novartis Investigative Site, Tel Aviv, Israel; Recruiting
Additional Information
Starting date: April 2010
Last updated: November 22, 2011
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