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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Procedure: Malnutrition screening and perioperative nutritional support
- 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.
- 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)
- 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
- 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)
- 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)
- 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)
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
|Contact: Marc BONNEFOY, Pr||(0)4 78 86 15 81 ext +email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Marc BONNEFOY, Pr||Hospices Civils de Lyon|