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)”

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)

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine, memantine

Primary Measures

• Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)

Secondary Measures

• Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair 862-778-8300  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00305903

Study ID Number: CENA713BUS32

ClinicalTrials.gov Identifier: NCT00305903

Health Authority: United States: Food and Drug Administration