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Official title Single-center Prospective Longitudinal Study of Taste in Patients With Cognitive Disorders at Different Stages of Severity (Isolated Cognitive Complaint, Minor or Major Neurocognitive Alzheimer-type Disorders) by Analysis of Gustatory Evoked Potentials
ClinicalTrials.gov ID: NCT05888961
What this study is testing
What is Blood samples?
Blood samples is an investigational medicine, being studied as a potential treatment for cognitive disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 4 following groups of participants: Healthy subjects Participants with isolated cognitive complaint Participants with minor neurocognitive disorder Participants with mild and moderate Alzheimer-type major neurocognitive disorders For this purpose, we want to compare the results of the following tests: Subjective taste tests (tasting solutions, answering food preference questionnaires), Gustatory evoked potential (GEP) parameters, recorded by electrodes placed on the scalp, And nutritional parameters (hormones of food intake by blood test, measurement of the global body composition). Identifying and following the evolution of early taste disorders in case of cognitive disorders could improve the diagnosis of Alzheimer\'s disease in two ways: To allow an early diagnosis of Alzheimer\'s disease, and thus improve its management, To define groups of subjects at risk of developing Alzheimer\'s disease in later years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Person who has given oral consent.
- For patients with mild to moderate Alzheimer\'s disease, the primary caregiver and the patient will be asked to provide oral consent
- Person of legal age
- Body Mass Index (BMI) \< 30 kg/m².
- For the healthy group: absence of cognitive complaints and normal neurological assessment
You likely can't join if
- MMSE score\<15
- Known COVID-19 infection within 6 months prior to inclusion
- Person not affiliated to national health insurance system
- Person under a legal protection measure (curatorship, guardianship)
- Person subject to a measure of legal protection
- Pregnant, parturient or breastfeeding women
See the full eligibility criteria
- Person who has given oral consent.
- For patients with mild to moderate Alzheimer\'s disease, the primary caregiver and the patient will be asked to provide oral consent
- Person of legal age
- Body Mass Index (BMI) \< 30 kg/m².
- For the healthy group: absence of cognitive complaints and normal neurological assessment
- Patients meeting the criteria for isolated cognitive complaint: presence of cognitive complaint but normal neuropsychological evaluation
- Patients meeting diagnostic criteria for minor cognitive impairment: imaging (brain MRI) and neuropsychological assessment with a Clinical Dementia Rating (CDR) score of 0.5
- Patients meeting diagnostic criteria for mild to moderate Alzheimer\'s disease: imaging (brain MRI), neuropsychobiological criteria (consultation with neuropsychological assessment, CSF biomarkers), MMSE score ≥ 20 and...
- Fasting for at least 2 hours before GEP measurement
- MMSE score\<15
- Known COVID-19 infection within 6 months prior to inclusion
- Person not affiliated to national health insurance system
- Person under a legal protection measure (curatorship, guardianship)
- Person subject to a measure of legal protection
- Pregnant, parturient or breastfeeding women
- people with a pacemaker (contraindication to bioelectrical impedance measurement)
- Adult unable to express consent or to perform cognitive tests.
- Active smoker (\> 4 cigarettes per day on a regular basis)
- Diabetic subject (type 1 or type 2)
- Subject with acute or chronic ENT disease
- Treatment interfering with gustation
- Brain MRI showing another cause of neurocognitive disorder (except for vascular lesions Fazekas 1 accepted)
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.