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

Sponsor:	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

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

Resource links provided by NLM:

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

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

No publications provided

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

Keywords provided by Novartis:

Dementia,
Alzheimer's,
Rivastigmine,
Memantine

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Rivastigmine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012