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Cytokines and Cognitive Decline in Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01351142
First received: May 6, 2011
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351142

Contacts
Contact: Marc PACCALIN, Professor, MD, Ph +33 5 49 44 44 27 m.paccalin@chu-poitiers.fr

Locations
France
CHU Angers - service Gérontologie clinique Recruiting
Angers, France, 49933
Contact: Olivier BEAUCHET, MD         olbeauchet@chu-angers.fr    
Principal Investigator: Olivier BEAUCHET, MD            
Hôpital Dupuytren - CHU de Limoges Recruiting
Limoges, France, MD
Contact: Thierry DANTOINE, MD         thierry.dantoine@chu-limoges.fr    
Principal Investigator: Thierry DANTOINE, MD            
CHU de NANTES - service Gériatrie Recruiting
Nantes, France, 44000
Contact: Gilles BERRUT, MD         gilles.berrut@chu-nantes.fr    
Principal Investigator: Gilles BERRUT, MD            
CHU DE NANTES - Centre ambulatoire de Gérontologie clinique Recruiting
Nantes, France, 44046
Contact: Sophie PICHIERRI, MD         sophie.pichierri@chu-nantes.fr    
Principal Investigator: Sophie PICHIERRI, MD            
Hôpital Pitié Salpétrière Recruiting
Paris, France, 75651
Contact: Marc VERNY, MD         marc.verny@psl.aphp.fr    
Principal Investigator: Marc VERNY, MD            
Hôpital Broca - service de Gériatrie Recruiting
Paris, France, 75013
Contact: Olivier HANON, MD         olivier.hanon@brc.aphp.fr    
Principal Investigator: Olivier HANON, MD            
Chu de Poitiers - Recruiting
Poitiers, France, 86021
Contact: Marc ¨PACCALIN, MD     +33 5 49 44 44 27     m.paccalin@chu-poitiers.fr    
Principal Investigator: Marc PACCALIN, MD            
Sub-Investigator: Pierre-Jean SAULNIER, MD            
Chu Strasbourg Not yet recruiting
Strasbourg, France, 67981
Contact: Frédéric BLANC, MD         frederic.blanc@chru-strasbourg.com    
Principal Investigator: Frédéric BLANC, MD            
CHU de TOURS - service de Gériatrie Recruiting
Tours, France, 37044
Contact: Caroline HOMMET, MD         hommet@med.univ-tours.fr    
Principal Investigator: Caroline HOMMET, MD            
Hôpital gériatrique des Charpennes Recruiting
Villeurbanne, France, 69100
Contact: Pierre KROLAK-SALMON, MD         pierre.krolak-salmon@chu-lyon.fr    
Sub-Investigator: Géraldine MARTIN GAUJARD, MD            
Principal Investigator: Pierre KROMAK-SALMON, MD            
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01351142     History of Changes
Other Study ID Numbers: CYTOCOGMA
Study First Received: May 6, 2011
Last Updated: May 10, 2011
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013