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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00305903

Purpose

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)

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Rivastigmine, memantine	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Nausea and Vomiting

Drug Information available for: Memantine Memantine hydrochloride Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	March 2006
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305903

Locations

United States, New Jersey

Manchester, New Jersey, United States, 08759

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

862-778-8300

More Information

Study ID Numbers:	CENA713BUS32
Study First Received:	March 20, 2006
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00305903
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Dementia,
Alzheimer's,
Rivastigmine,
Memantine

Study placed in the following topic categories:

Excitatory Amino Acids
Rivastigmine
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders

Delirium, Dementia, Amnestic, Cognitive Disorders
Dopamine
Mental Disorders
Memantine
Dementia
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Enzyme Inhibitors
Excitatory Amino Acid Agents
Cholinergic Agents

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Therapeutic Uses
Dopamine Agents
Tauopathies
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009