Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Malnutrition screening and perioperative nutritional support.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
- 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]
Secondary outcome measures (5)
- cognitive profile evaluation at inclusion phase [Time frame: at baseline (day 0)]
- Présence of cardiovascular risk factor [Time frame: at baseline (day 0)]
- treatment evaluation [Time frame: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months]
- Functionality [Time frame: at baseline (day 0) and at day hospital visit if need be (up to 48 months)]
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon. — Pierre-Bénite
Identifiers
NCT: NCT02800395 · 2014.860