Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials. (MAPEG)
Primary Purpose
Cognitive Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Cognitive Assessment
Subjective taste tests
Objective taste tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Cognitive Disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- - 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
- 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
Sites / Locations
- Chu Dijon Bourgogne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Major Cognitive Impairment
Minor Cognitive Impairment
No Cognitive Impairment
Arm Description
Outcomes
Primary Outcome Measures
Amplitude of gustatory evoked potentials
Latency of the gustatory evoked potential
Secondary Outcome Measures
Full Information
NCT ID
NCT04860414
First Posted
April 22, 2021
Last Updated
December 14, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04860414
Brief 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.
Acronym
MAPEG
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
June 17, 2021 (Actual)
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
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.
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Major Cognitive Impairment
Arm Type
Experimental
Arm Title
Minor Cognitive Impairment
Arm Type
Experimental
Arm Title
No Cognitive Impairment
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Fasting blood glucose, dosage of acylated and non-acylated ghrelin, leptin, insulin and serotonin.
Intervention Type
Other
Intervention Name(s)
Cognitive Assessment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Subjective taste tests
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Objective taste tests
Intervention Description
Recording of gustatory evoked potentials
Primary Outcome Measure Information:
Title
Amplitude of gustatory evoked potentials
Time Frame
After a fasting period of 2 hours
Title
Latency of the gustatory evoked potential
Time Frame
After a fasting period of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
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
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
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Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials.
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