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

Novartis

Status and phase

Completed

Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Rivastigmine, memantine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00305903

CENA713BUS32

Details and patient eligibility

About

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)

Enrollment

150 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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