Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00149175
First received: September 6, 2005
Last updated: March 12, 2010
Last verified: March 2010
  Purpose

Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. 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 Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network is already set up for Alzheimer'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 not 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 use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (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 in the study of neurological disorders of genetic origin.


Condition Intervention Phase
Alzheimer's Disease
Dementia
Neurodegenerative Disorders
Other: Blood sampling, skin biopsy
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Estimated Enrollment: 4000
Study Start Date: December 2002
Estimated Study Completion Date: October 2007
Groups/Cohorts Assigned Interventions
Neurodegenerative disorders with cognitive impairment Other: Blood sampling, skin biopsy
Blood sampling, skin biopsy in the field of the medical follow-up
Control Other: Blood sampling, skin biopsy
Blood sampling, skin biopsy in the field of the medical follow-up
At risk reactive Other: Blood sampling, skin biopsy
Blood sampling, skin biopsy in the field of the medical follow-up

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Patients presenting with a neurodegenerative disorder
  • At risk patients
Criteria

Inclusion Criteria:

  • Patients presenting with 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
  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: NCT00149175

Contacts
Contact: Alexis Brice, MD 0033142162182 brice@ccr.jussieu.fr

Locations
France
CHU de la Côte de Nacre Recruiting
Caen, France, 14000
Contact: Gilles Defer, MD, PhD         
Principal Investigator: Gilles Defer, MD, PhD         
Sub-Investigator: Isabelle Le Ber, MD         
Hôpital Sainte-Marguerite Recruiting
Marseille, France, 13009
Contact: Bernard-François Michel, MD    0033491744949    bmichel@ap-hm.fr   
Principal Investigator: Bernard-François Michel, MD         
Hôpital Guillaume et René Laennec Recruiting
Nantes, France, 44000
Contact: Martine Vercelletto, MD    0033240165422    mvercelletto@chu-nantes.fr   
Principal Investigator: Martine Vercelletto, MD         
Hôpital de l'Archet Recruiting
Nice, France, 06000
Contact: Claude Desnuelle, MD, PhD    0033492035505    desnuelle.c@chu-nice.fr   
Principal Investigator: Claude Desnuelle, MD, PhD         
Sub-Investigator: Marie-Hélène Soriani, MD         
Pitié-Salpêtrière Hospital - Fédération de Neurologie Recruiting
Paris, France, 75013
Contact: Vincent Meininger, MD, PhD       vincent.meininger@psl.aphp.fr   
Principal Investigator: Vincent Meininger, MD, PhD         
Sub-Investigator: Lucette Lacomblez, MD         
Sub-Investigator: François Salachas, MD         
Pitié-Salpêtrière Hospital - Centre du Langage et de Neuropsychologie Recruiting
Paris, France, 75013
Contact: Bruno Dubois, MD    0033142161777    b.dubois@psl.ap-hop-paris.fr   
Principal Investigator: Bruno Dubois, MD         
Pitié-Salpêtrière Hospital Recruiting
Paris, France, 75013
Contact: Alexis Brice, MD    0033142162182    brice@ccr.jussieu.fr   
Principal Investigator: Alexis Brice, MD         
Sub-Investigator: Isabelle Le Ber, MD         
Hôpital Pontchaillou Recruiting
Rennes, France, 35000
Contact: Serge Belliard, MD    0033299284293    belliard.s@voila.fr   
Principal Investigator: Serge Belliard, MD         
Sub-Investigator: Véronique Golfier, MD         
Hôpital Charles Nicolle Recruiting
Rouen, France, 76000
Contact: Didier Hannequin, MD, PhD    0033232888170    Didier.hannequin@chu-rouen.fr   
Principal Investigator: Didier Hannequin, MD, PhD         
Centre Hospitalier Recruiting
Saint-Brieuc, France, 22000
Contact: Véronique Golfier, MD    0033296017454    veronique.golfier@ch-stbrieuc.fr   
Principal Investigator: Véronique Golfier, MD         
Hôpital Bellevue Recruiting
Saint-Etienne, France, 42000
Contact: Catherine Thomas-Antérion, MD    0033477127805    catherine.thomas@chu-st-etienne.fr   
Principal Investigator: Catherine Thomas-Antérion, MD         
Hôpital Civil Recruiting
Strasbourg, France, 67000
Contact: François Sellal, MD    0033388116892    Francois.Sellal@chru-strasbourg.fr   
Principal Investigator: François Sellal, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Aventis Pharmaceuticals
Investigators
Principal Investigator: Alexis Brice, MD Assistance Publique - Hôpitaux de Paris, University Paris 6
  More Information

Additional Information:
Publications:

Responsible Party: Alexis Brice, Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00149175     History of Changes
Other Study ID Numbers: 02-156, 02-346A10
Study First Received: September 6, 2005
Last Updated: March 12, 2010
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Alzheimer's disease
Dementia
Phenotype-genotype correlations
Candidate genes
Related disorders

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Disease
Cognition Disorders
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014