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NCT Number: NCT02800395

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pierre-Bénite, 69495, France

Location status: Recruiting

Location contact

Marc BONNEFOY, Pr

CONTACT

[email protected]

(0)4 78 86 15 81 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

    Time frame: 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 outcomes

  1. cognitive profile evaluation at inclusion phase

    Time frame: 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)

  2. Présence of cardiovascular risk factor

    Time frame: 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

  3. treatment evaluation

    Time frame: 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)

  4. Functionality

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

    Katz and Lawton scores ( ADL/ IADL)

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marc BONNEFOY, Pr

CONTACT

[email protected]

(0)4 78 86 15 81 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: GERIOX

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2016
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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