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

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Procedure: Malnutrition screening and perioperative nutritional support

• Registration Number: NCT02800395
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional evaluation	Malnutrition screening and perioperative nutritional support	-

Primary Outcome Measures

Name	Time	Method
Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.	at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months	Patient cognitive profile evolution measured by successive MMSE score evaluations during follow-up memory consultation, every 6 months until patient loss.

Secondary Outcome Measures

Name	Time	Method
Functionality	at baseline (day 0) and at day hospital visit if need be (up to 48 months)	Katz and Lawton scores ( ADL/ IADL)
cognitive profile evaluation at inclusion phase	at baseline (day 0)	Dubois's "5 words" test; free recall test; cued recall memory test; Trail Making Test Part A/Trail Making Test Part B (TMTA/TMTB)
Présence of cardiovascular risk factor	at baseline (day 0)	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
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)	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)
treatment evaluation	at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months	drugs list, posology, indication Drug type (ACE inhibitors; NSAIDs; statins...) angiotensin-converting-enzyme inhibitor (ACE inhibitor) Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs)

Trial Locations

Locations (1)

Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.; 🇫🇷 Pierre Benite, France