Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease (GERIOX)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Marc BONNEFOY, Pr
- Numero di telefono: +33 (0)4 78 86 15 81
- Email: marc.bonnefoy@chu-lyon.fr
Luoghi di studio
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Pierre Benite, Francia, 69495
- Reclutamento
- Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
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Contatto:
- Marc BONNEFOY, Pr
- Numero di telefono: +33 (0)4 78 86 15 81
- Email: marc.bonnefoy@chu-lyon.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Altro: Nutritional evaluation
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.
Lasso di tempo: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
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Patient cognitive profile evolution measured by successive MMSE score evaluations during follow-up memory consultation, every 6 months until patient loss.
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at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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cognitive profile evaluation at inclusion phase
Lasso di tempo: at baseline (day 0)
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Dubois's "5 words" test; free recall test; cued recall memory test; Trail Making Test Part A/Trail Making Test Part B (TMTA/TMTB)
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at baseline (day 0)
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Présence of cardiovascular risk factor
Lasso di tempo: at baseline (day 0)
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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
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at baseline (day 0)
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treatment evaluation
Lasso di tempo: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
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drugs list, posology, indication Drug type (ACE inhibitors; NSAIDs; statins…) angiotensin-converting-enzyme inhibitor (ACE inhibitor) Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs)
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at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
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Functionality
Lasso di tempo: at baseline (day 0) and at day hospital visit if need be (up to 48 months)
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Katz and Lawton scores ( ADL/ IADL)
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at baseline (day 0) and at day hospital visit if need be (up to 48 months)
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Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI
Lasso di tempo: At day hospital visit if need be (up to 48 months)
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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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At day hospital visit if need be (up to 48 months)
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marc BONNEFOY, Pr, Hospices Civils de Lyon
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2014.860
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