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)

Novartis0 sites150 target enrollmentMarch 2006

ConditionsAlzheimer's Disease

DrugsRivastigmine, memantine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Novartis
Enrollment: 150
Primary Endpoint: Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

August 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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