Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Rivastigmine, memantine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: 862-778-8300
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. 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)
Clinical Details
Official title: A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
Secondary outcome: Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Manchester, New Jersey 08759, United States
Additional Information
Starting date: March 2006
Ending date: August 2007
Last updated: December 17, 2007
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