Clinical trial NCT02800395: Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
Official title: Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer
oxydative stress
nutrition
biomarkers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 350
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: According to several reports, the oxidative stress and the nutrition could have an impact in the Alzheimer disease.

The association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders.

This is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints.

The objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments.

The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of MRI contraindication) will be realized during the study inclusion phase in the usual intake of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the Day hospital dedicated to the routine intake of patients issued from the memory consultation.

In this study, the principal evaluation criteria will be the MMSE score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. It will allow evaluating the correlation between the cognitive decline evolution measured by MMSE during the Alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.


Eligibility criteria: Inclusion Criteria:

* \>55 years old patient
* Patient seen during a memory consultation in geriatric Unit, Lyon Sud University Hospital
* Patient or legal representative and/or person of confidence who didn't express his opposition to the clinical assay participation.
* Patient registered to the general social insurance
* Complementary health check scheduled at day hospital, conventional hospitalization or regular consultation.

Exclusion Criteria:

* Patient unable to express his participation refusal and under curatorship or unforced by the court of justice

Primary outcomes:
measure: Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.
timeFrame: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Secondary outcomes:
measure: cognitive profile evaluation at inclusion phase
timeFrame: at baseline (day 0)
measure: Présence of cardiovascular risk factor
timeFrame: at baseline (day 0)
measure: treatment evaluation
timeFrame: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
measure: Functionality
timeFrame: at baseline (day 0) and at day hospital visit if need be (up to 48 months)
measure: Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI
timeFrame: At day hospital visit if need be (up to 48 months)
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
Study officials:
affiliation: Hospices Civils de Lyon
name: Marc BONNEFOY, Pr
role: PRINCIPAL_INVESTIGATOR
References: