Status:
COMPLETED
Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease
Lead Sponsor:
Novartis
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy...
Eligibility Criteria
Inclusion
- Have a diagnosis of probable Alzheimer's disease;
- Have an MMSE score between 10 and 20;
- Must be able to swallow capsule/tablet;
- Must have a caregiver who is able to attend all study visits;
Exclusion
- Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
- Have a current diagnosis of active, uncontrolled seizure disorder;
- Have a history within the past year or current diagnosis of cerebrovascular disease
- Have a current diagnosis of severe or unstable cardiovascular disease;
- Had a myocardial infarction (MI) within the last six months;
- Have specific respiratory, digestive, renal, or endocrine disorders;
- Have had previous treatment with rivastigmine or memantine;
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00305903
Start Date
March 1 2006
End Date
August 1 2007
Last Update
December 21 2007
Active Locations (1)
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1
Paterson, New Jersey, United States, 08759