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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
  Purpose

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 Intervention
Alzheimer's Disease
Other: blood test and cognitive tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Enrollment: 133
Study Start Date: November 2009
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
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: NCT01351142

Locations
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

ClinicalTrials.gov Identifier: NCT01351142     History of Changes
Other Study ID Numbers: CYTOCOGMA 
Study First Received: May 6, 2011
Last Updated: October 10, 2016
Health Authority: France : Agence Française de sécurité sanitaire des produits de santé

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016