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Cytokines and Cognitive Decline in Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01351142
First received: May 6, 2011
Last updated: October 10, 2016
Last verified: October 2016
May 6, 2011
October 10, 2016
November 2009
November 2013   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01351142 on ClinicalTrials.gov Archive Site
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Cytokines and Cognitive Decline in Alzheimer's Disease
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Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD.

The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up.

Secondary objectives include:

  • the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)
  • correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.
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Interventional
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Intervention Model: Single Group Assignment
Alzheimer's Disease
Other: blood test and cognitive tests
Specific cognitive tests are performed at day 1, month 6, one year and 2 years Specific Blood samples tests are performed at inclusion, 1 years and 2 years
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
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November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Alzheimer's disease (AD)patients
  • MMSE score: 16-25
  • Written informed consent

Exclusion Criteria:

  • AD patients with specific treatment for AD before inclusion MMSE score under 16 or over 25 at inclusion
  • patients with anti-inflammatory drugs (non steroids or corticosteroids) or immunosuppressive agents
  • Patients with acute disease (infectious disease, rheumatologic disease) or chronic disease (malignancy, infectious, rheumatologic disease) that could interact with plasma cytokines level
  • Patients with a life threatening disease
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01351142
CYTOCOGMA
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Poitiers University Hospital
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Poitiers University Hospital
October 2016

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