Cytokines and Cognitive Decline in Alzheimer's Disease

October 10, 2016 updated by: Poitiers University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU Angers - service Gérontologie clinique
      • Limoges, France, MD
        • Hôpital Dupuytren - CHU de Limoges
      • Nantes, France, 44000
        • CHU de NANTES - service Gériatrie
      • Nantes, France, 44046
        • CHU DE NANTES - Centre ambulatoire de Gérontologie clinique
      • Paris, France, 75651
        • Hopital Pitie Salpetriere
      • Paris, France, 75013
        • Hôpital Broca - service de Gériatrie
      • Poitiers, France, 86021
        • Chu de Poitiers -
      • Strasbourg, France, 67981
        • CHU Strasbourg
      • Tours, France, 37044
        • CHU de TOURS - service de Gériatrie
      • Villeurbanne, France, 69100
        • Hôpital gériatrique des Charpennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYTOCOGMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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