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

Last updated: December 17, 2007
Sponsor: Novartis
Overall Status: Completed

Phase

4

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00305903
CENA713BUS32
  • Ages 50-85
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Have an advanced, severe, progressive, or unstable disease of any type that mayinterfere 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 Design

Total Participants: 150
Study Start date:
March 01, 2006
Estimated Completion Date:
August 31, 2007

Connect with a study center

  • Manchester, New Jersey 08759
    United States

    Site Not Available

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