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
NCT ID: NCT05888961
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
72 participants
INTERVENTIONAL
2023-06-12
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sensitivity of Basic Taste in Elderly
NCT03196440
Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING)
NCT04036162
Study of Neurophysiological Correlates of the Link Between Perception and Action
NCT02851121
Integrative Study of Vestibular Pathology
NCT05525728
Cognitive Function Assessment in Patients With Focal Brain Injury
NCT04182087
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control subjects
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
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
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.
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
Computerized food preference questionnaires
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
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.
Subjects with an isolated cognitive complaint
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
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
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.
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
Computerized food preference questionnaires
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
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.
Subjects with minor neurocognitive disorders
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
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
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.
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
Computerized food preference questionnaires
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
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.
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
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
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
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.
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
Computerized food preference questionnaires
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
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.
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
Computerized food preference questionnaires
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 CDR score of 1 or 1.5
* Fasting for at least 2 hours before GEP measurement
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Dijon Bourgogne
Dijon, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JACQUIN 2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.