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

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ClinicalTrials.gov Identifier: NCT02800395
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Procedure: Malnutrition screening and perioperative nutritional support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
Study Start Date : December 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Nutritional evaluation 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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800395


Contacts
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Contact: Marc BONNEFOY, Pr (0)4 78 86 15 81 ext +33 marc.bonnefoy@chu-lyon.fr

Locations
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France
Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon. Recruiting
Pierre Benite, France, 69495
Contact: Marc BONNEFOY, Pr    (0)4 78 86 15 81 ext +33    marc.bonnefoy@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Marc BONNEFOY, Pr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02800395     History of Changes
Other Study ID Numbers: 2014.860
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Keywords provided by Hospices Civils de Lyon:
Alzheimer
oxydative stress
nutrition
biomarkers
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders