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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

September 6, 2005
March 12, 2010
December 2002
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Complete list of historical versions of study NCT00149175 on ClinicalTrials.gov Archive Site
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Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment
Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
  • Patients presenting with a neurodegenerative disorder
  • At risk patients
  • Alzheimer's Disease
  • Dementia
  • Neurodegenerative Disorders
Other: Blood sampling, skin biopsy
Blood sampling, skin biopsy in the field of the medical follow-up
  • Neurodegenerative disorders with cognitive impairment
    Intervention: Other: Blood sampling, skin biopsy
  • Control
    Intervention: Other: Blood sampling, skin biopsy
  • At risk reactive
    Intervention: Other: Blood sampling, skin biopsy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
October 2007
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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
Both
18 Years to 90 Years
Yes
Contact: Alexis Brice, MD 0033142162182 brice@ccr.jussieu.fr
France
 
NCT00149175
02-156, 02-346A10
Not Provided
Alexis Brice, Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Aventis Pharmaceuticals
Principal Investigator: Alexis Brice, MD Assistance Publique - Hôpitaux de Paris, University Paris 6
Institut National de la Santé Et de la Recherche Médicale, France
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP