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

Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305903
• Other study ID #: CENA713BUS32
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2006
• Last updated: December 17, 2007
• Start date: March 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine, memantine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
Secondary	Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy