Cytokines and Cognitive Decline in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351142
• Other study ID #: CYTOCOGMA
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: October 10, 2016
• Start date: November 2009

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers - service Gérontologie clinique	Angers
France	Hôpital Dupuytren - CHU de Limoges	Limoges
France	CHU DE NANTES - Centre ambulatoire de Gérontologie clinique	Nantes
France	CHU de NANTES - service Gériatrie	Nantes
France	Hôpital Broca - service de Gériatrie	Paris
France	Hôpital Pitié Salpétrière	Paris
France	Chu de Poitiers -	Poitiers
France	Chu Strasbourg	Strasbourg
France	CHU de TOURS - service de Gériatrie	Tours
France	Hôpital gériatrique des Charpennes	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France,