Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease

NCT02800395 | Recruiting

• 1 other identifier: 2014.860
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer; oxydative stress; nutrition; biomarkers

Outcome Measures

Primary Outcomes (1)

• Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.

  Patient cognitive profile evolution measured by successive MMSE score evaluations during follow-up memory consultation, every 6 months until patient loss.

  at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months

Secondary Outcomes (5)

• cognitive profile evaluation at inclusion phase

  at baseline (day 0)

• Présence of cardiovascular risk factor

  at baseline (day 0)

• treatment evaluation

  at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months

• Functionality

  at baseline (day 0) and at day hospital visit if need be (up to 48 months)

• Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI

  At day hospital visit if need be (up to 48 months)

Study Arms (1)

Nutritional evaluation

OTHER

Procedure: Malnutrition screening and perioperative nutritional support

Interventions

Malnutrition screening and perioperative nutritional support PROCEDURE

* Multidisciplinary training sessions for malnutrition and malnutrition risk screening, postoperative nutritional procedures according to the ESPEN Guidelines * Preoperative Geriatric evaluation : eligibility criteria, nutritional status, previous history, comorbidities, clinical examination, activities of daily living (ADL) and Instrumental activities of daily living (IADL) * Implementation of an adapted nutritional support based on ESPEN Guidelines

Nutritional evaluation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marc BONNEFOY, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc BONNEFOY, Pr

CONTACT

(0)4 78 86 15 81; marc.bonnefoy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 15, 2016
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

FR (1)