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

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:

Genetics Home Reference related topics: CHMP2B-related frontotemporal dementia GRN-related frontotemporal dementia frontotemporal dementia with parkinsonism-17 inclusion body myopathy with early-onset Paget disease and frontotemporal dementia

MedlinePlus related topics: Dementia

Drug Information available for: Memantine Memantine hydrochloride

Genetic and Rare Diseases Information Center resources: Pick's Disease Frontotemporal Dementia Frontotemporal Dementia, Ubiquitin-positive Primary Progressive Aphasia Semantic 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Boutoleau-Bretonnière C, Lebouvier T, Volteau C, Jaulin P, Lacomblez L, Damier P, Thomas-Anterion C, Vercelletto M. Prospective evaluation of behavioral scales in the behavioral variant of frontotemporal dementia. Dement Geriatr Cogn Disord. 2012;34(2):75-82. Epub 2012 Aug 23.

Vercelletto M, Boutoleau-Bretonnière C, Volteau C, Puel M, Auriacombe S, Sarazin M, Michel BF, Couratier P, Thomas-Antérion C, Verpillat P, Gabelle A, Golfier V, Cerato E, Lacomblez L; French research network on Frontotemporal dementia. Memantine in behavioral variant frontotemporal dementia: negative results. J Alzheimers Dis. 2011;23(4):749-59. doi: 10.3233/JAD-2010-101632.


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 Neurocognitive 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 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

ClinicalTrials.gov processed this record on September 27, 2016