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

NCT00200538 | Completed Phase 2

• 1 other identifier: BRD 05/1-E
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

frontotemporal dementia; Mémantine; Patients with frontotemporal dementia

Interventions

memantine DRUG

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Martine Vercelletto

Nantes, 44093, France

Location

Related Publications (2)

• Boutoleau-Bretonniere 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. doi: 10.1159/000341784. Epub 2012 Aug 23.

  PMID: 22922703 DERIVED

• Vercelletto M, Boutoleau-Bretonniere C, Volteau C, Puel M, Auriacombe S, Sarazin M, Michel BF, Couratier P, Thomas-Anterion 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.

  PMID: 21157021 DERIVED

MeSH Terms

Conditions

Dementia; Frontotemporal Dementia

Interventions

Memantine

Condition Hierarchy (Ancestors)

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; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Martine Vercelletto, MD

  Centre de la Mémoire, Clinique Neurologique CHU Nord Nantes 44093 France; mvercelletto@chu-nantes.fr

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2005
• Last Updated: May 3, 2013

Record last verified: 2005-01

Locations

FR (1)