Alzheimer DiseaseGERIOXNCT02800395
Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
A study testing Malnutrition screening and perioperative nutritional support in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Malnutrition screening and perioperative nutritional support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- Patient unable to express his participation refusal and under curatorship or unforced by the court of justice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
Pierre-Bénite, 69495
Marc BONNEFOY, Pr, (0)4 78 86 15 81 ext. +33, marc.bonnefoy@chu-lyon.fr
About this study
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.
Read more
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.
- Conditions
- Alzheimer Disease
- Being tested
- Malnutrition screening and perioperative nutritional support
- Keywords
- Alzheimer, oxydative stress, nutrition, biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malnutrition screening and perioperative nutritional supportProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Nutritional evaluation | Other | Not described Receives: Procedure: Malnutrition screening and perioperative nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Secondary outcomes (5)
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)
Measured: at baseline (day 0)
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
Measured: at baseline (day 0)
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)
Measured: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Functionality
Katz and Lawton scores ( ADL/ IADL)
Measured: 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
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)
Measured: At day hospital visit if need be (up to 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc BONNEFOY, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800395
- Sponsor's protocol ID
- 2014.860
- Acronym
- GERIOX
- Status last verified
- Apr 2021
- First submitted
- 30 May 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
- ClinicalTrials.gov ID
- NCT02800395
- Acronym / sponsor ID
- GERIOX / 2014.860
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, oxydative stress, nutrition, biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional evaluation | Other | Procedure: Malnutrition screening and perioperative nutritional support |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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.
Key exclusion criteria (1 listed)
- Patient unable to express his participation refusal and under curatorship or unforced by the court of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Nutritional evaluation |
Primary outcome
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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc BONNEFOY, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malnutrition screening and perioperative nutritional support in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc BONNEFOY, Pr ((0)4 78 86 15 81 ext. +33, marc.bonnefoy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.