Status:
COMPLETED
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for t...
Eligibility Criteria
Inclusion
- Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
- MMSE score of ≥10 and ≤ 26;
Exclusion
- Bradycardia (beats per minute less than 50)
- Body weight less than 40 kg;
- Hypersensitivity to cholinesterase inhibitors.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00731224
Start Date
July 1 2008
End Date
October 1 2011
Last Update
March 28 2017
Active Locations (40)
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1
Novartis Investigative Site
East Gosford, New South Wales, Australia, 2250
2
Novartis Investigative Site
Gosford, New South Wales, Australia, 2250
3
Novartis Investigative Site
Hornsby, New South Wales, Australia, 2077
4
Novartis Investigative Site
Randwick, New South Wales, Australia, 2031