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Dementia

Senility




Clinical Trial: Neurodegenerative Disorders

This study is currently recruiting patients.
Verified by Institut National de la Santé Et de la Recherche Médicale, France September 2005

Sponsors and Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Aventis Pharmaceuticals
Information provided by: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00149175

Purpose

Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-up. A blood sample will be proposed in the field of this research project, and the biological material will be stored at the DNA and Cell bank of IFR of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network are already set up for Amzheimer’s disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol.

Among these disorders, a monogenic sub-group has been identified. In Alzheimer’s disease, it is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial forms with early onset. In frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. The identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms non caused by the known genes, using linkage approaches and candidate gene analysis. The familial forms are also useful for identifying the modifier genes.

In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. The strategies will used a candidate gene approach, and in the near future, studies of SNPs spread out in the whole genome. Meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment.

Finally, correlations will be performed with seric markers according to each kind of dementia.

Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and specialized teams in the study of neurological disorders of genetic origin.

Condition Phase
Alzheimer''''s Disease
Dementia
Related disorders
Phase I

MedlinePlus related topics:  Alzheimer''''s Caregivers;   Alzheimer''''s Disease;   Dementia
Genetics Home Reference related topics:  Alzheimer disease

Study Type: Observational
Study Design: Natural History, Longitudinal, Case Control, Prospective Study

Official Title: Clinical and Genetic Study of Neurodegenerative Disorders with Cognitive Impairment

Further Study Details: 

Expected Total Enrollment:  4000

Study start: December 2002;  Expected completion: December 2007
Last follow-up: October 2007;  Data entry closure: October 2007

Eligibility

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

- patients presenting a neurodegenerative disorder with cognitive impairment controls (without signs of the disease, matched with sex and age with the patients, relatives for the familial cases

Exclusion Criteria:

- Pregnant women, minors, persons refusing to sign the informed consent

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00149175

Alexis Brice, MD      0033142162182    brice@ccr.jussieu.fr

France
      Centre Hospitalier, Saint-Brieuc,  22000,  France; Recruiting
Véronique Golfier, MD  0033296017454    veronique.golfier@ch-stbrieuc.fr 
Véronique Golfier, MD,  Principal Investigator

      CHU de la Côte de Nacre, Caen,  14000,  France; Recruiting
Gilles Defer, MD, PhD
Gilles Defer, MD, PhD,  Principal Investigator
Isabelle Le Ber, MD,  Sub-Investigator

      Hôpital Bellevue, Saint-Etienne,  42000,  France; Recruiting
Catherine Thomas-Antérion, MD  0033477127805    catherine.thomas@chu-st-etienne.fr 
Catherine Thomas-Antérion, MD,  Principal Investigator

      Hôpital Charles Nicolle, Rouen,  76000,  France; Recruiting
Didier Hannequin, MD, PhD  0033232888170    Didier.hannequin@chu-rouen.fr 
Didier Hannequin, MD, PhD,  Principal Investigator

      Hôpital Civil, Strasbourg,  67000,  France; Recruiting
François Sellal, MD  0033388116892    Francois.Sellal@chru-strasbourg.fr 
François Sellal, MD,  Principal Investigator

      Hôpital de l''''Archet, Nice,  06000,  France; Recruiting
Claude Desnuelles, MD, PhD  0033492035505    desnuelle.c@chu-nice.fr 
Claude Desnuelle, MD, PhD,  Principal Investigator
Marie-Hélène Soriani, MD,  Sub-Investigator

      Hôpital Guillaume et René Laennec, Nantes,  44000,  France; Recruiting
Martine Vercelletto, MD  0033240165422    mvercelletto@chu-nantes.fr 
Martine Vercelletto, MD,  Principal Investigator

      Hôpital Pontchaillou, Rennes,  35000,  France; Recruiting
Serge Belliard, MD  0033299284293    belliard.s@voila.fr 
Serge Belliard, MD,  Principal Investigator
Véronique Golfier, MD,  Sub-Investigator

      Hôpital Sainte-Marguerite, Marseille,  13009,  France; Recruiting
Bernard-François Michel, MD  0033491744949    bmichel@ap-hm.fr 
Bernard-François Michel, MD,  Principal Investigator

      Pitié-Salpêtrière Hospital - Centre du Langage et de Neuropsychologie, Paris,  75013,  France; Recruiting
Bruno Dubois, MD  0033142161777    b.dubois@psl.ap-hop-paris.fr 
Bruno Dubois, MD,  Principal Investigator

      Pitié-Salpêtrière Hospital - Fédération de Neurologie, Paris,  75013,  France; Recruiting
Vincent Meininger, MD, PhD   vincent.meininger@psl.aphp.fr 
Vincent Meininger, MD, PhD,  Principal Investigator
Lucette Lacomblez, MD,  Sub-Investigator
François Salachas, MD,  Sub-Investigator

      Pitié-Salpêtrière Hospital, Paris,  75013,  France; Recruiting
Alexis Brice, MD  0033142162182    brice@ccr.jussieu.fr 
Alexis Brice, MD,  Principal Investigator
Isabelle Le Ber, MD,  Sub-Investigator

Study chairs or principal investigators

Alexis Brice, MD,  Principal Investigator,  Assistance Publique - Hôpitaux de Paris, University Paris 6   

More Information

Study ID Numbers:  02-156; 02-346A10
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149175
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13

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