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Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200538
First received: September 12, 2005
Last updated: May 2, 2013
Last verified: January 2005
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients

Resource links provided by NLM:

MedlinePlus related topics: Dementia
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Enrollment: 52
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

Locations
France
Martine Vercelletto
Nantes, France, 44093
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

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00200538     History of Changes
Other Study ID Numbers: BRD 05/1-E
Study First Received: September 12, 2005
Last Updated: May 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
frontotemporal dementia
Mémantine
Patients with frontotemporal dementia

Additional relevant MeSH terms:
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
 Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Memantine
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

ClinicalTrials.gov processed this record on June 18, 2013