Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease

Phase 4

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00305903
• Lead Sponsor: Novartis

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. 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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Study Completion: 2007-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-17
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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