Cognitive DisordersMAPEG 2NCT05888961
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
A study testing Blood samples, Interviewing the subject and scales and Neurocognitive evaluation in people with Cognitive Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Disorders
- What is being tested?
- Blood samples, Interviewing the subject and scales and Neurocognitive evaluation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to Dec 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
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
Chu Dijon Bourgogne
Dijon
Agnès JACQUIN-PIQUES, 03.80.29.37.54, agnes.jacquin-piques@chu-dijon.fr
About this study
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
Read more
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.
- Conditions
- Cognitive Disorders
- Being tested
- Blood samples, Interviewing the subject and scales, Neurocognitive evaluation, Taste tests, Computerized food preference questionnaires
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
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 scalesOther
Collection of sociodemographic data, personal and family neurological history, treatments, MADRS depression scale and CDR autonomy scale.
Carried out at the 1st session
Neurocognitive evaluationOther
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 testsOther
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 questionnairesOther
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
Nutritional status - body compositionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control subjects | Active comparator | Not described Receives: Biological: Blood samples; Other: Interviewing the subject and scales; Other: Neurocognitive evaluation; Other: Taste tests; Other: Computerized food preference questionnaires; Other: Nutritional status - body composition |
| Subjects with an isolated cognitive complaint | Experimental | Not described Receives: Biological: Blood samples; Other: Interviewing the subject and scales; Other: Neurocognitive evaluation; Other: Taste tests; Other: Computerized food preference questionnaires; Other: Nutritional status - body composition |
| Subjects with minor neurocognitive disorders | Experimental | Not described Receives: Biological: Blood samples; Other: Interviewing the subject and scales; Other: Neurocognitive evaluation; Other: Taste tests; Other: Computerized food preference questionnaires; Other: Nutritional status - body composition |
| Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type | Experimental | Not described Receives: Biological: Blood samples; Other: Interviewing the subject and scales; Other: Neurocognitive evaluation; Other: Taste tests; Other: Computerized food preference questionnaires; Other: Nutritional status - body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the gustatory evoked potentials
Measured: After a 2-hour fasting period
Gustatory evoked potentials latency
Measured: After a 2-hour fasting period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start12 Jun 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888961
- Sponsor's protocol ID
- JACQUIN 2023
- Acronym
- MAPEG 2
- Status last verified
- Sep 2026
- First submitted
- 25 May 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- MAPEG 2 / JACQUIN 2023
- Conditions
- Cognitive Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control subjects | Active comparator | Biological: Blood samples, Other: Interviewing the subject and scales, Other: Neurocognitive evaluation, Other: Taste tests, Other: Computerized food preference questionnaires, Other: Nutritional status - body composition |
| Subjects with an isolated cognitive complaint | Experimental | Biological: Blood samples, Other: Interviewing the subject and scales, Other: Neurocognitive evaluation, Other: Taste tests, Other: Computerized food preference questionnaires, Other: Nutritional status - body composition |
| Subjects with minor neurocognitive disorders | Experimental | Biological: Blood samples, Other: Interviewing the subject and scales, Other: Neurocognitive evaluation, Other: Taste tests, Other: Computerized food preference questionnaires, Other: Nutritional status - body composition |
| Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type | Experimental | Biological: Blood samples, Other: Interviewing the subject and scales, Other: Neurocognitive evaluation, Other: Taste tests, Other: Computerized food preference questionnaires, Other: Nutritional status - body composition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Blood samplesFasting 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 | Biological | Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders |
| Interviewing the subject and scalesCollection of sociodemographic data, personal and family neurological history, treatments, MADRS depression scale and CDR autonomy scale. Carried out at the 1st session | Other | Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders |
| Neurocognitive evaluationcognitive 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. | Other | Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders |
| Taste testsSweet 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 | Other | Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders |
| Computerized food preference questionnairesPerformed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up. | Other | Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders |
| Nutritional status - body compositionMeasurement 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. | Other | Control subjects, Subjects with an isolated cognitive complaint, Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type, Subjects with minor neurocognitive disorders |
Primary outcome
Amplitude of the gustatory evoked potentials
Time frame: After a 2-hour fasting period
Gustatory evoked potentials latency
Time frame: After a 2-hour fasting period
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 25 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples, Interviewing the subject and scales and Neurocognitive evaluation in people with Cognitive Disorders, run by Centre Hospitalier Universitaire Dijon 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 9 inclusion and 13 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 25 Sep 2026. 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 Agnès JACQUIN-PIQUES (03.80.29.37.54, agnes.jacquin-piques@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of the gustatory evoked potentials (time frame: After a 2-hour fasting period). The study lists 2 primary outcomes in all. 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 25 Sep 2026.