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

Novartis150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Alzheimer's Disease

Interventions

Rivastigmine, memantineDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Paterson, New Jersey, United States

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

Data from ClinicalTrials.gov

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