NCT05888961

Brief 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 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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jun 2023Jul 2027

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

4.1 years

First QC Date

May 25, 2023

Last Update Submit

July 8, 2025

Conditions

Cognitive Disorders

Outcome Measures

Primary Outcomes (2)

  • Amplitude of the gustatory evoked potentials

    After a 2-hour fasting period

  • Gustatory evoked potentials latency

    After a 2-hour fasting period

Study Arms (4)

Control subjects

ACTIVE COMPARATOR
Biological: Blood samplesOther: Interviewing the subject and scalesOther: Neurocognitive evaluationOther: Taste testsOther: Computerized food preference questionnairesOther: Nutritional status - body composition

Subjects with an isolated cognitive complaint

EXPERIMENTAL
Biological: Blood samplesOther: Interviewing the subject and scalesOther: Neurocognitive evaluationOther: Taste testsOther: Computerized food preference questionnairesOther: Nutritional status - body composition

Subjects with minor neurocognitive disorders

EXPERIMENTAL
Biological: Blood samplesOther: Interviewing the subject and scalesOther: Neurocognitive evaluationOther: Taste testsOther: Computerized food preference questionnairesOther: Nutritional status - body composition

Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type

EXPERIMENTAL
Biological: Blood samplesOther: Interviewing the subject and scalesOther: Neurocognitive evaluationOther: Taste testsOther: Computerized food preference questionnairesOther: Nutritional status - body composition

Interventions

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

Control subjectsSubjects with an isolated cognitive complaintSubjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease typeSubjects with minor neurocognitive disorders
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

Control subjectsSubjects with an isolated cognitive complaintSubjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease typeSubjects with minor neurocognitive disorders
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.

Control subjectsSubjects with an isolated cognitive complaintSubjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease typeSubjects with minor neurocognitive disorders
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

Control subjectsSubjects with an isolated cognitive complaintSubjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease typeSubjects with minor neurocognitive disorders
Computerized food preference questionnairesOTHER

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

Control subjectsSubjects with an isolated cognitive complaintSubjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease typeSubjects with minor neurocognitive disorders
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.

Control subjectsSubjects with an isolated cognitive complaintSubjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease typeSubjects with minor neurocognitive disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • MMSE score\<15
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Blood Specimen CollectionWeights and Measures

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Agnès JACQUIN-PIQUES

CONTACT

03.80.29.37.54agnes.jacquin-piques@chu-dijon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations

FR(1)