Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00234637

Purpose

This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Efficacy and Safety of Add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

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:

The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).

Secondary Outcome Measures:

Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline

Estimated Enrollment:	200
Study Start Date:	November 2003
Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine

Exclusion Criteria:

Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234637

Locations

France, Cedex
Département de Gérontologie Clinique
Limoges, Cedex, France, 87042

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Thierry Dantoine

Centre Hospitalier Universitaire

More Information

No publications provided

Study ID Numbers:	CENA713BFR05
Study First Received:	October 5, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00234637 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Alzheimer's disease,
switch,
rivastigmine,
memantine

Additional relevant MeSH terms:

Neurotransmitter Agents
Rivastigmine
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Neurodegenerative Diseases
Brain Diseases
Cholinergic Agents
Neuroprotective Agents
Mental Disorders
Therapeutic Uses
Memantine

Dementia
Excitatory Amino Acid Antagonists
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Dopamine Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009