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Cytokines and Cognitive Decline in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01351142
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : October 11, 2016
Sponsor:
Information provided by:
Poitiers University Hospital

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: blood test and cognitive tests Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Study Start Date : November 2009
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351142


Locations
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France
CHU Angers - service Gérontologie clinique
Angers, France, 49933
Hôpital Dupuytren - CHU de Limoges
Limoges, France, MD
CHU de NANTES - service Gériatrie
Nantes, France, 44000
CHU DE NANTES - Centre ambulatoire de Gérontologie clinique
Nantes, France, 44046
Hôpital Broca - service de Gériatrie
Paris, France, 75013
Hôpital Pitié Salpétrière
Paris, France, 75651
Chu de Poitiers -
Poitiers, France, 86021
Chu Strasbourg
Strasbourg, France, 67981
CHU de TOURS - service de Gériatrie
Tours, France, 37044
Hôpital gériatrique des Charpennes
Villeurbanne, France, 69100
Sponsors and Collaborators
Poitiers University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT01351142    
Other Study ID Numbers: CYTOCOGMA
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders