Clinical trial
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
Name
JACQUIN 2023
Description
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.
Trial arms
Trial start
2023-06-12
Estimated PCD
2026-07-01
Trial end
2026-07-01
Status
Recruiting
Treatment
Blood samples
Fasting at the first session for hormonal measurements of leptin, insulin, acylated and non-acylated ghrelin, serotonin, albumin, protidemia and blood glucose.
Repeated at 6 and 12 months for follow-up
Arms:
Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild Alzheimer's disease type, Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders
Interviewing the subject and scales
Collection of sociodemographic data, personal and family neurological history, treatments, MADRS depression scale and CDR autonomy scale.
Carried out at the 1st session
Arms:
Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild Alzheimer's disease type, Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders
Neurocognitive evaluation
cognitive complaint questionnaire (CCQ), taste, smell, MoCA and MMSE (if not performed in the previous 6 months) Carried out at the 1st session. Repeated at 6 and 12 months for follow-up.
Arms:
Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild Alzheimer's disease type, Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders
Taste tests
Sweet and salty flavors at the 1st session and acid and umami flavors at the 2nd session. Repeated at 6 and 12 months for follow-up.
Placement of electrodes on the scalp, recording of gustatory evoked potentials, subjective gustatory evaluation by means of visual analogue scales rated from 0 to 10, identification and naming of each of the primary flavors
Arms:
Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild Alzheimer's disease type, Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders
Computerized food preference questionnaires
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
Arms:
Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild Alzheimer's disease type, Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders
Nutritional status - body composition
Measurement of anthropometric data, bioelectrical impedancemetry (measurement of fat mass, lean mass, water mass and bone mass in kg), measurement of blood pressure and heart rate Performed at the 2nd session Repeated at 6 and 12 months for follow-up.
Arms:
Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild Alzheimer's disease type, Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders
Size
125
Primary endpoint
Amplitude of the gustatory evoked potentials
After a 2-hour fasting period
Gustatory evoked potentials latency
After a 2-hour fasting period
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 125, 'type': 'ESTIMATED'}}
Updated at
2023-06-15
1 organization
Organization
Centre Hospitalier Universitaire Dijon