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

December 17, 2007 updated by: Novartis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Manchester, New Jersey, United States, 08759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, 862-778-8300

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713BUS32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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