Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients - Full Text View

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200538

Purpose

The purpose of this trial is to assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in frontotemporal dementia patients after a one-year treatment.

Condition	Intervention	Phase
Dementia	Drug: memantine	Phase II

MedlinePlus related topics: Dementia

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients

Further study details as provided by Nantes University Hospital:

Estimated Enrollment:	64
Study Start Date:	September 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with FTD based on the criteria defined by the Lund and Manchester groups' consensus statement (revised in 1998), whose disease has been progressing during the last year.
MMSE score of 19 or higher
Men and women aged 45 to 75 years
Without speech, visuospatial, or episodic memory impairments

Exclusion Criteria:

Age > 76 years
Illiterate or misunderstanding patients
Patients with cancer, heart disease, lung disease, kidney disease (creatinine > 200 mg/dL), or epilepsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200538

Contacts

Contact: Martine Vercelletto, MD

00 33 2 40 016 54 22

mvercelletto@chu-nantes.fr

Locations

France
Martine Vercelletto	Recruiting
Nantes, France, 44093
Contact: Martine Vercelletto, MD 00 32 02 40 16 54 22 mvercelletto@chu-nantes.fr
Principal Investigator: Martine Vercelletto, MD

Sponsors and Collaborators

Nantes University Hospital

Investigators

Study Director:	Martine Vercelletto, MD	Centre de la Mémoire, Clinique Neurologique CHU Nord Nantes 44093 France; mvercelletto@chu-nantes.fr
Principal Investigator:	Lucette Lacomblez, MD	Federation de Neurologie AP-HP Paris 75 013 France; lucette.lacomblez@psl.ap-hop-paris.fr
Principal Investigator:	Bruno Dubois, MD	Centre du Langage et de Neuropsychologie AP-HP Paris 75013 France; b.dubois@psl.ap-hop-paris.fr
Principal Investigator:	Anne Sophie Rigaud, MD	Hôpital Broca, Paris 75 France; anne-sophie.rigaud@brc.ap-hop-paris.fr
Principal Investigator:	Jean-Francois Dartigues, MD	Hôpital Pellegrin Bordeaux 33 076 France; jean-francois.dartigues@u.bordeaux2.fr
Principal Investigator:	Sophie Auriacombe, MD	Hôpital Pellegrin Bordeaux 33 076 France ; sophie.auriacombe@u.bordeaux.fr
Principal Investigator:	Philippe Couratier, MD	Hôpital Dupuytren, Limoges 87000 France; philippe.couratier@unilim.fr
Principal Investigator:	Jacques Touchon, MD	Hôpital Gui de Chaulliac, Montpellier 34 295 France; jacques.touchon@wanadoo.fr
Principal Investigator:	Matthieu Ceccaldi, MD	Hôpital de la Timone Marseille 13 005 France; mceccaldi@ap-hm.fr
Principal Investigator:	Mira Didic, MD	Hôpital de la Timone Marseille 13005 France; mira.didic@medecine.univ-mrs.fr
Principal Investigator:	Serge Bakchine, MD	Hôpital Maison Blanche, Reims 51 092 France; sbakchine@chu-reims.fr
Principal Investigator:	Bernard-Francois Michel, MD	Hôpital Sainte Marguerite, 13009 France; bmichel@ap-hm.fr
Principal Investigator:	Catherine Thomas-Anterion, MD	Hôpital Bellevue Saint Etienne, 42 000 France; catherine.thomas@chu-st-etienne.fr
Principal Investigator:	Bernard Laurent, MD	Hôpital Bellevue Saint Etienne 42 000 France; bernard.laurent@univ-st-etienne.fr
Principal Investigator:	Francois Sellal, MD	Hôpital Civil Strasbourg 67000 France; francois.sellal@chru-strasbourg.fr
Principal Investigator:	Serge Belliard, MD	Hôpital Pontchaillou Rennes 35 000, France; serge.belliard@chu-rennes.fr
Principal Investigator:	Herve Allain, MD	Service de Pharmacologie, CHU de Rennes 35 000 France ; Herve.allain@univ-rennes1.fr
Principal Investigator:	Michele Puel, MD	Hôpital Purpan, Toulouse 31059 France; PUEL.M@chu-toulouse.fr
Principal Investigator:	Jean-Francois Demonet, MD	Clinique Neurologique CHU Purpan Toulouse 31059 France; demonet@toulouse.inserm.fr
Principal Investigator:	Marie Sarazin, MD	Centre du Langage et de la Mémoire, Hôpital de la Salpétriére AP-HP Paris 75013 France

More Information

Study ID Numbers:	BRD 05/1-E
Study First Received:	September 12, 2005
Last Updated:	January 16, 2007
ClinicalTrials.gov Identifier:	NCT00200538
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

frontotemporal dementia
Mémantine
Patients with frontotemporal dementia

Study placed in the following topic categories:

Excitatory Amino Acids
Pick Disease of the Brain
Speech Disorders
Frontotemporal dementia
Aphasia
Central Nervous System Diseases
Language Disorders
Brain Diseases
Aphasia, Primary Progressive
Cognition Disorders
Signs and Symptoms
Dopamine

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Neurologic Manifestations
Lobar atrophy of brain
Primary progressive aphasia
Dementia
Neurobehavioral Manifestations
Pick disease of the brain
Communication Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Antiparkinson Agents
Excitatory Amino Acid Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009