NCT02800395Recruiting
Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
Source: ClinicalTrials.gov · Last updated 30 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 30 May 2016
- Start date
- Dec 2014
- Primary completion date
- Dec 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Alzheimer disease
- NCT number
- NCT02800395
What you commit to
- Study type: Interventional
- Planned participants: 350
- From Dec 2014 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient unable to express his participation refusal and under curatorship or unforced by the court of justice
Who the study is looking for
- \>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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon. Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.