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

Alzheimer Disease Clinical Trial

— GERIOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02800395
• Other study ID #: 2014.860
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2026

Study information

• Verified date: April 2021
• Source: Hospices Civils de Lyon
• Contact: Marc BONNEFOY, Pr
• Phone: (0)4 78 86 15 81
• Email: marc.bonnefoy[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Procedure:
• Malnutrition screening and perioperative nutritional support
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

Locations

Country	Name	City	State
France	Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cognitive profile evaluation at inclusion phase	Dubois's "5 words" test; free recall test; cued recall memory test; Trail Making Test Part A/Trail Making Test Part B (TMTA/TMTB)	at baseline (day 0)
Secondary	Présence of cardiovascular risk factor	arterial hypertension; Tobacco: estimated consumption in cigarettes pack per year; lipidemia: cholesterol, high-density lipoprotein cholesterol (HDLc), Triglycerides, low-density lipoprotein cholesterol (LDLc); diabetes: diabetes fasting blood glucose, HbA1c; prior cardiovascular histories: acute coronary syndrome, arteriopathy	at baseline (day 0)
Secondary	treatment evaluation	drugs list, posology, indication Drug type (ACE inhibitors; NSAIDs; statins…) angiotensin-converting-enzyme inhibitor (ACE inhibitor) Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs)	at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Secondary	Functionality	Katz and Lawton scores ( ADL/ IADL)	at baseline (day 0) and at day hospital visit if need be (up to 48 months)
Secondary	Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI	Description: cortical atrophy; specific hippocampus cortex atrophy ( according to Sheltens classification); subcortical atrophy; vascular Leukoencephalopathy symptoms on T2-FLAIR sequence; micro-bleeds in T2 sequence; Iron deposition observed by MRI method (or CT scans if MRI is contraindicated)	At day hospital visit if need be (up to 48 months)