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

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Malnutrition screening and perioperative nutritional support
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer, oxydative stress, nutrition, biomarkers

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nutritional evaluation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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
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)
Functionality
Katz and Lawton scores ( ADL/ IADL)
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)

Full Information

First Posted
May 30, 2016
Last Updated
April 29, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02800395
Brief Title
Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
Acronym
GERIOX
Official Title
Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer, oxydative stress, nutrition, biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional evaluation
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Malnutrition screening and perioperative nutritional support
Intervention Description
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 Measure Information:
Title
Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.
Description
Patient cognitive profile evolution measured by successive MMSE score evaluations during follow-up memory consultation, every 6 months until patient loss.
Time Frame
at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Secondary Outcome Measure Information:
Title
cognitive profile evaluation at inclusion phase
Description
Dubois's "5 words" test; free recall test; cued recall memory test; Trail Making Test Part A/Trail Making Test Part B (TMTA/TMTB)
Time Frame
at baseline (day 0)
Title
Présence of cardiovascular risk factor
Description
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
Time Frame
at baseline (day 0)
Title
treatment evaluation
Description
drugs list, posology, indication Drug type (ACE inhibitors; NSAIDs; statins…) angiotensin-converting-enzyme inhibitor (ACE inhibitor) Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs)
Time Frame
at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Title
Functionality
Description
Katz and Lawton scores ( ADL/ IADL)
Time Frame
at baseline (day 0) and at day hospital visit if need be (up to 48 months)
Title
Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI
Description
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)
Time Frame
At day hospital visit if need be (up to 48 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BONNEFOY, Pr
Phone
(0)4 78 86 15 81
Ext
+33
Email
marc.bonnefoy@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, Pr
Phone
(0)4 78 86 15 81
Ext
+33
Email
marc.bonnefoy@chu-lyon.fr

12. IPD Sharing Statement

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

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