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Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients
This study has been completed.
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200538
First received: September 12, 2005
Last updated: May 2, 2013
Last verified: January 2005
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
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
Genetic and Rare Diseases Information Center resources:
Semantic Dementia
Frontotemporal Dementia
Frontotemporal Dementia, Ubiquitin-positive
Pick's Disease
Primary Progressive Aphasia
U.S. FDA Resources
Further study details as provided by Nantes University Hospital:
Show Detailed Description
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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):
| 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 |
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 June 27, 2017