Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease
Completed · Phase 4
Conditions studied: Alzheimer's Disease
In brief
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. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)
Key facts
- Study ID
- NCT00305903
- Run by
- Novartis
- People needed
- 150
- Starts
- 2006-03-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2007-12-21
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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
Where it is running
- Study site — Paterson, New Jersey, United States
Full record on ClinicalTrials.gov
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