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

Tracking Information

First Received Date ^ICMJE

May 6, 2011

Last Updated Date

May 10, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01351142 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cytokines and Cognitive Decline in Alzheimer's Disease

Official Title ^ICMJE

Not Provided

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marc PACCALIN, Professor, MD, Ph

+33 5 49 44 44 27

m.paccalin@chu-poitiers.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01351142

Other Study ID Numbers ^ICMJE

CYTOCOGMA

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Poitiers University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Poitiers University Hospital

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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