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NCT Number: NCT05888961

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

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.

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Key information

Conditions

Cognitive Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

  • 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)

Treatment and study plan

blood samples

Biological

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

Other

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

Other

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

Other

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

Other

Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.

Nutritional status - body composition

Other

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.

Primary outcomes

  1. Amplitude of the gustatory evoked potentials

    Time frame: After a 2-hour fasting period

  2. Gustatory evoked potentials latency

    Time frame: After a 2-hour fasting period

Study contacts

Contact information is provided by the study sponsor or research team.

Agnès JACQUIN-PIQUES

CONTACT

[email protected]

03.80.29.37.54

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: MAPEG 2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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