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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 (MAPEG 2)

Primary Purpose

Cognitive Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Interviewing the subject and scales
Neurocognitive evaluation
Taste tests
Computerized food preference questionnaires
Nutritional status - body composition
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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 Patients meeting diagnostic criteria for moderate Alzheimer's disease: imaging (brain MRI), neuropsychobiological criteria (consultation with neuropsychological workup, CSF biomarkers), MMSE score 15≤ 20, and CDR score of 1.5 or 2 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)

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Control subjects

Subjects with an isolated cognitive complaint

Subjects with minor neurocognitive disorders

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

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

Arm Description

Outcomes

Primary Outcome Measures

Amplitude of the gustatory evoked potentials
Gustatory evoked potentials latency

Secondary Outcome Measures

Full Information

First Posted
May 25, 2023
Last Updated
June 14, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05888961
Brief 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
Acronym
MAPEG 2
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 5 following groups of participants: Healthy subjects Participants with isolated cognitive complaint Participants with minor neurocognitive disorder Participants with mild Alzheimer-type major neurocognitive disorders Participants with 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control subjects
Arm Type
Active Comparator
Arm Title
Subjects with an isolated cognitive complaint
Arm Type
Experimental
Arm Title
Subjects with minor neurocognitive disorders
Arm Type
Experimental
Arm Title
Subjects with major neurocognitive disorders of the mild Alzheimer's disease type
Arm Type
Experimental
Arm Title
Subjects with major neurocognitive disorders of the moderate Alzheimer's disease type
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Interviewing the subject and scales
Intervention Description
Collection of sociodemographic data, personal and family neurological history, treatments, MADRS depression scale and CDR autonomy scale. Carried out at the 1st session
Intervention Type
Other
Intervention Name(s)
Neurocognitive evaluation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Taste tests
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Computerized food preference questionnaires
Intervention Description
Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up.
Intervention Type
Other
Intervention Name(s)
Nutritional status - body composition
Intervention Description
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 Outcome Measure Information:
Title
Amplitude of the gustatory evoked potentials
Time Frame
After a 2-hour fasting period
Title
Gustatory evoked potentials latency
Time Frame
After a 2-hour fasting period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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 Patients meeting diagnostic criteria for moderate Alzheimer's disease: imaging (brain MRI), neuropsychobiological criteria (consultation with neuropsychological workup, CSF biomarkers), MMSE score 15≤ 20, and CDR score of 1.5 or 2 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès JACQUIN-PIQUES
Phone
03.80.29.37.54
Email
agnes.jacquin-piques@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès JACQUIN-PIQUES
Phone
03.80.29.37.54
Email
agnes.jacquin-piques@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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