Cognitive DisordersMAPEGNCT04860414
Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials.
A study testing Blood sampling, Cognitive Assessment and Subjective taste tests in people with Cognitive Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Approximately 24 million people worldwide suffer from dementia, with Alzheimer's disease being the most common cause. Alzheimer's disease typically progresses in three stages: presymptomatic, prodromal ("early onset" or minor cognitive impairment) and major cognitive impairment with loss of autonomy and significant… 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 sampling, Cognitive Assessment and Subjective taste tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2021to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- A person who has given oral consent.
- For patients with early stage Alzheimer's disease, both the primary caregiver and the patient will need to give oral consent.
- ADULT
- Body Mass Index (BMI) < 30 kg/m².
- Patients meeting the diagnostic criteria for early-stage Alzheimer's disease: imaging (cerebral MRI), neuropsychobiological criteria (consultation with neuropsychological assessment, CSF biomarkers) and CDR (Clinical Dementia Rating Scale) rated at 1 or 1.5 - for the "subjects with early-stage Alzheimer's disease" group
- Patients meeting the diagnostic criteria for minor cognitive impairment: imaging (brain MRI) and neuropsychological assessment with a CDR scale of 0.5 - for the group "subjects with minor cognitive impairment".
- Absence of cognitive problems and normal neurological assessment - for the healthy group.
- Fasting at least 2 hours before PEG measurement
Who cannot join
- - A person who is not affiliated to or not a beneficiary of a social security system.
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to a judicial safeguard measure
- Pregnant, parturient or breastfeeding woman
- Adult unable to express consent or perform cognitive testing.
- Minor
Show all 14Show fewer
- No Caregiver for Mild Alzheimer's Disease Patients
- Active smoker
- Diabetes (type 1 or type 2)
- Taking a treatment that interferes with taste
- Body Mass Index (BMI) ≥ 30 kg/m2
- MMS Score <20
- Cerebral MRI finding another cause of neurocognitive disorder (except for Fazekas 1 vascular lesions accepted).
- Known COVID-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials
Approximately 24 million people worldwide suffer from dementia, with Alzheimer's disease being the most common cause. Alzheimer's disease typically progresses in three stages: presymptomatic, prodromal ("early onset" or minor cognitive impairment) and major cognitive impairment with loss of autonomy and significant psycho-behavioral symptoms. Efforts to counteract its expansion are increasing, and there is a need for biomarkers to identify the disease in its earliest stage in order to provide prompt treatment.
Faced with a episodic memory disorder, it is possible, thanks to certain criteria, highlighted by neuroimaging, or by biomarkers obtained by biological analysis of cerebrospinal fluid (during a lumbar puncture), to detect Alzheimer's disease from the prodromal stage, or even earlier. The main limitation of these criteria is their invasive nature. Other non-invasive biomarkers would therefore be useful to help diagnose Alzheimer's disease at an early stage. Gustatory evoked potentials (GEP), a technique for exploring taste sensory pathways, could meet these needs.
Read more
Indeed, GEPs are a method of exploring the gustatory sensory pathway based on the recording of cerebral electrical activity by electroencephalography (EEG). It is a painless, accessible, inexpensive and non-invasive technique. The alteration of gustatory functions is present in many neurological conditions, but often takes second place to sensory or motor symptoms. Rare studies have studied taste in patients with Alzheimer's disease, but they have demonstrated, using subjective tests only, an early gustatory impairment linked to a degeneration of the gustatory cortex. It was observed that the performance of subjects with minor or major cognitive impairment was weaker than that of healthy subjects, without the patient being aware of these taste disorders.
The aim of the study is to explore taste functions in patients with minor cognitive impairment, major cognitive impairment such as mild Alzheimer's disease, by comparing them to healthy subjects. For this purpose, we wish to compare the results of subjective taste tests (tasting solutions, especially salty ones, answering food preference questionnaires), parameters of taste evoked potentials recorded by electrodes stuck on the scalp and hormonal parameters obtained by blood sampling, between the three groups of subjects mentioned.
- Conditions
- Cognitive Disorders
- Being tested
- Blood sampling, Cognitive Assessment, Subjective taste tests, Objective taste tests
- 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 samplingBiological
Fasting blood glucose, dosage of acylated and non-acylated ghrelin, leptin, insulin and serotonin.
Cognitive AssessmentOther
QPC Cognitive complaint questionnaire, CDR functional autonomy scales and IADL 4 items, MMSE cognitive scores, Dubois 5-word test, clock test, BREF, Isaacs test, BARD naming battery and MADRS depression scale
Subjective taste testsOther
Scales of taste perceptive intensity, taste pleasure, hunger sensation (visual analogue scales from 0 to 10 cm) and food preferences on the one hand, and on the other hand, subjective tests of taste threshold determination by triangular tests of increasing sugar solution concentrations.
Objective taste testsOther
Recording of gustatory evoked potentials
| Study group | Role | What they receive |
|---|---|---|
| Major Cognitive Impairment | Experimental | Not described Receives: Biological: Blood sampling; Other: Cognitive Assessment; Other: Subjective taste tests; Other: Objective taste tests |
| Minor Cognitive Impairment | Experimental | Not described Receives: Biological: Blood sampling; Other: Cognitive Assessment; Other: Subjective taste tests; Other: Objective taste tests |
| No Cognitive Impairment | Active comparator | Not described Receives: Biological: Blood sampling; Other: Cognitive Assessment; Other: Subjective taste tests; Other: Objective taste tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of gustatory evoked potentials
Measured: After a fasting period of 2 hours
Latency of the gustatory evoked potential
Measured: After a fasting period of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start3 Mar 2021
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
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
- NCT04860414
- Sponsor's protocol ID
- JACQUIN 2020
- Acronym
- MAPEG
- Status last verified
- Dec 2022
- First submitted
- 22 Apr 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Kadiri W, Perrignon-Sommet M, Delpont B, Graber M, Mohr S, Mouillot T, Devilliers H, Grall S, Lienard F, Georges M, Brindisi MC, Brondel L, Bejot Y, Leloup C, Jacquin-Piques A. Changes in Taste Perception in Patients with Minor and Major Cognitive Impairment Linked to Alzheimer's Disease Recorded by Gustatory Evoked Potentials. J Alzheimers Dis. 2023;96(4):1593-1607. doi: 10.3233/JAD-230270.
PubMed 38007646
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials
- ClinicalTrials.gov ID
- NCT04860414
- Acronym / sponsor ID
- MAPEG / JACQUIN 2020
- Conditions
- Cognitive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 27 Apr 2021 (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.
Approximately 24 million people worldwide suffer from dementia, with Alzheimer's disease being the most common cause. Alzheimer's disease typically progresses in three stages: presymptomatic, prodromal ("early onset" or minor cognitive impairment) and major cognitive impairment with loss of autonomy and significant psycho-behavioral symptoms. Efforts to counteract its expansion are increasing, and there is a need for biomarkers to identify the disease in its earliest stage in order to provide prompt treatment.
Faced with a episodic memory disorder, it is possible, thanks to certain criteria, highlighted by neuroimaging, or by biomarkers obtained by biological analysis of cerebrospinal fluid (during a lumbar puncture), to detect Alzheimer's disease from the prodromal stage, or even earlier. The main limitation of these criteria is their invasive nature. Other non-invasive biomarkers would therefore be useful to help diagnose Alzheimer's disease at an early stage. Gustatory evoked potentials (GEP), a technique for exploring taste sensory pathways, could meet these needs.
Indeed, GEPs are a method of exploring the gustatory sensory pathway based on the recording of cerebral electrical activity by electroencephalography (EEG). It is a painless, accessible, inexpensive and non-invasive technique. The alteration of gustatory functions is present in many neurological conditions, but often takes second place to sensory or motor symptoms. Rare studies have studied taste in patients with Alzheimer's disease, but they have demonstrated, using subjective tests only, an early gustatory impairment linked to a degeneration of the gustatory cortex. It was observed that the performance of subjects with minor or major cognitive impairment was weaker than that of healthy subjects, without the patient being aware of these taste disorders.
The aim of the study is to explore taste functions in patients with minor cognitive impairment, major cognitive impairment such as mild Alzheimer's disease, by comparing them to healthy subjects. For this purpose, we wish to compare the results of subjective taste tests (tasting solutions, especially salty ones, answering food preference questionnaires), parameters of taste evoked potentials recorded by electrodes stuck on the scalp and hormonal parameters obtained by blood sampling, between the three groups of subjects mentioned.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Major Cognitive Impairment | Experimental | Biological: Blood sampling, Other: Cognitive Assessment, Other: Subjective taste tests, Other: Objective taste tests |
| Minor Cognitive Impairment | Experimental | Biological: Blood sampling, Other: Cognitive Assessment, Other: Subjective taste tests, Other: Objective taste tests |
| No Cognitive Impairment | Active comparator | Biological: Blood sampling, Other: Cognitive Assessment, Other: Subjective taste tests, Other: Objective taste tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A person who has given oral consent.
- For patients with early stage Alzheimer's disease, both the primary caregiver and the patient will need to give oral consent.
- ADULT
- Body Mass Index (BMI) < 30 kg/m².
- Patients meeting the diagnostic criteria for early-stage Alzheimer's disease: imaging (cerebral MRI), neuropsychobiological criteria (consultation with neuropsychological assessment, CSF biomarkers) and CDR (Clinical Dementia Rating Scale) rated at 1 or 1.5 - for the "subjects with early-stage Alzheimer's disease" group
Key exclusion criteria (14 listed)
- - A person who is not affiliated to or not a beneficiary of a social security system.
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to a judicial safeguard measure
- Pregnant, parturient or breastfeeding woman
- Adult unable to express consent or perform cognitive testing.
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 samplingFasting blood glucose, dosage of acylated and non-acylated ghrelin, leptin, insulin and serotonin. | Biological | Major Cognitive Impairment, Minor Cognitive Impairment, No Cognitive Impairment |
| Cognitive AssessmentQPC Cognitive complaint questionnaire, CDR functional autonomy scales and IADL 4 items, MMSE cognitive scores, Dubois 5-word test, clock test, BREF, Isaacs test, BARD naming battery and MADRS depression scale | Other | Major Cognitive Impairment, Minor Cognitive Impairment, No Cognitive Impairment |
| Subjective taste testsScales of taste perceptive intensity, taste pleasure, hunger sensation (visual analogue scales from 0 to 10 cm) and food preferences on the one hand, and on the other hand, subjective tests of taste threshold determination by triangular tests of increasing sugar solution concentrations. | Other | Major Cognitive Impairment, Minor Cognitive Impairment, No Cognitive Impairment |
| Objective taste testsRecording of gustatory evoked potentials | Other | Major Cognitive Impairment, Minor Cognitive Impairment, No Cognitive Impairment |
Primary outcome
Amplitude of gustatory evoked potentials
Time frame: After a fasting period of 2 hours
Latency of the gustatory evoked potential
Time frame: After a fasting period of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 38007646El Kadiri W, Perrignon-Sommet M, Delpont B, Graber M, Mohr S, Mouillot T, Devilliers H, Grall S, Lienard F, Georges M, Brindisi MC, Brondel L, Bejot Y, Leloup C, Jacquin-Piques A. Changes in Taste Perception in Patients with Minor and Major Cognitive Impairment Linked to Alzheimer's Disease Recorded by Gustatory Evoked Potentials. J Alzheimers Dis. 2023;96(4):1593-1607. doi: 10.3233/JAD-230270.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 sampling, Cognitive Assessment and Subjective taste tests 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 6 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of gustatory evoked potentials (time frame: After a fasting period of 2 hours). 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?
On the ClinicalTrials.gov record for NCT04860414, which also lists 1 linked publication.
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 6 Oct 2026.