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Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Publications: details revised at 5 of 5 entriesv13
  2. Notable Study completion date changed from estimate of Oct 2007 to Dec 31, 2020 Trial status: Recruiting to Completed · Enrollment target: estimated 4000 to confirmed 2256 · Primary completion date: Dec 31, 2020 · 2 morev12 Show all 6 changesShow less
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 4000 to confirmed 2256
    • Primary completion date: Dec 31, 2020
    • Site details revised at 12 of 12 sites
    • Publications: details revised at 5 of 5 entries
  3. Minor Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Eligibilityv11
  4. Minor Publications: 3 to 5v10 Show moreShow less
  5. Minor Publications: 1 to 3v9 Show moreShow less
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Publications expanded, about 81 wordsv8 Show moreShow less
  2. Minor 3 versions Re-verified since Feb 10, 2006, no change to tracked fieldsv5-v7
  3. Minor Site contacts updated at 1 of 12 sites Study title expanded, about 8 words · Eligibility criteria shortened, about 1 wordv4 Show all 3 changesShow less
    • Study title expanded, about 8 words
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Minor 2 versions Re-verified since Nov 18, 2005, no change to tracked fieldsv2-v3
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00149175
Lead Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Aventis Pharmaceuticals
Conditions Alzheimer's Disease, Dementia, Neurodegenerative Disorders
Enrollment 2,256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov