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

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ClinicalTrials.gov Identifier: NCT00200538
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 3, 2013
Information provided by:
Nantes University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Dementia Drug: memantine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2005

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200538

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Martine Vercelletto
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00200538    
Other Study ID Numbers: BRD 05/1-E
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: January 2005
Keywords provided by Nantes University Hospital:
frontotemporal dementia
Patients with frontotemporal dementia
Additional relevant MeSH terms:
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Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents