Cytokines and Cognitive Decline in Alzheimer's Disease

NCT ID: NCT01351142

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Locations

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CHU Angers - service Gérontologie clinique

Angers, , France

Site Status

Hôpital Dupuytren - CHU de Limoges

Limoges, , France

Site Status

CHU de NANTES - service Gériatrie

Nantes, , France

Site Status

CHU DE NANTES - Centre ambulatoire de Gérontologie clinique

Nantes, , France

Site Status

Hôpital Broca - service de Gériatrie

Paris, , France

Site Status

Hôpital Pitié Salpétrière

Paris, , France

Site Status

Chu de Poitiers -

Poitiers, , France

Site Status

Chu Strasbourg

Strasbourg, , France

Site Status

CHU de TOURS - service de Gériatrie

Tours, , France

Site Status

Hôpital gériatrique des Charpennes

Villeurbanne, , France

Site Status

Countries

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France

Other Identifiers

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CYTOCOGMA

Identifier Type: -

Identifier Source: org_study_id

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