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
Not Applicable
Recruiting
- Conditions
- Cognitive Disorders
- Interventions
- Biological: Blood samplesOther: Interviewing the subject and scalesOther: Neurocognitive evaluationOther: Taste testsOther: Computerized food preference questionnairesOther: Nutritional status - body composition
- Registration Number
- NCT05888961
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- Brief Summary
The aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 5 following groups of participants:
* Healthy subjects
* Participants with isolated cognitive complaint
* Participants with minor neurocognitive disorder
* Participants with mild Alzheimer-type major neurocognitive disorders
* Participants with 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
Inclusion 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 Alzheimer's disease: imaging (brain MRI), neuropsychobiological criteria (consultation with neuropsychological assessment, CSF biomarkers), MMSE score ≥ 20 and CDR score of 1 or 1.5
- Patients meeting diagnostic criteria for moderate Alzheimer's disease: imaging (brain MRI), neuropsychobiological criteria (consultation with neuropsychological workup, CSF biomarkers), MMSE score 15≤ 20, and CDR score of 1.5 or 2
- Fasting for at least 2 hours before GEP measurement
Exclusion Criteria
- 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
- Subjects 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control subjects Blood samples - Control subjects Interviewing the subject and scales - Control subjects Neurocognitive evaluation - Control subjects Taste tests - Control subjects Computerized food preference questionnaires - Control subjects Nutritional status - body composition - Subjects with an isolated cognitive complaint Blood samples - Subjects with an isolated cognitive complaint Interviewing the subject and scales - Subjects with an isolated cognitive complaint Neurocognitive evaluation - Subjects with an isolated cognitive complaint Taste tests - Subjects with an isolated cognitive complaint Computerized food preference questionnaires - Subjects with an isolated cognitive complaint Nutritional status - body composition - Subjects with minor neurocognitive disorders Blood samples - Subjects with minor neurocognitive disorders Interviewing the subject and scales - Subjects with minor neurocognitive disorders Neurocognitive evaluation - Subjects with minor neurocognitive disorders Taste tests - Subjects with minor neurocognitive disorders Computerized food preference questionnaires - Subjects with minor neurocognitive disorders Nutritional status - body composition - Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type Blood samples - Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type Interviewing the subject and scales - Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type Neurocognitive evaluation - Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type Taste tests - Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type Computerized food preference questionnaires - Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type Nutritional status - body composition -
- Primary Outcome Measures
Name Time Method Gustatory evoked potentials latency After a 2-hour fasting period Amplitude of the gustatory evoked potentials After a 2-hour fasting period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chu Dijon Bourgogne
🇫🇷Dijon, France