Cytokines and Cognitive Decline in Alzheimer's Disease
1 other identifier
interventional
133
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 6, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedOctober 11, 2016
October 1, 2016
4 years
May 6, 2011
October 10, 2016
Conditions
Interventions
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 Criteria
You may qualify if:
- Alzheimer's disease (AD)patients
- MMSE score: 16-25
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU Angers - service Gérontologie clinique
Angers, 49933, France
Hôpital Dupuytren - CHU de Limoges
Limoges, MD, France
CHU de NANTES - service Gériatrie
Nantes, 44000, France
CHU DE NANTES - Centre ambulatoire de Gérontologie clinique
Nantes, 44046, France
Hôpital Broca - service de Gériatrie
Paris, 75013, France
Hôpital Pitié Salpétrière
Paris, 75651, France
Chu de Poitiers -
Poitiers, 86021, France
Chu Strasbourg
Strasbourg, 67981, France
CHU de TOURS - service de Gériatrie
Tours, 37044, France
Hôpital gériatrique des Charpennes
Villeurbanne, 69100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2011
First Posted
May 10, 2011
Study Start
November 1, 2009
Primary Completion
November 1, 2013
Last Updated
October 11, 2016
Record last verified: 2016-10