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
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2021
CompletedFirst Submitted
Initial submission to the registry
April 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2021
CompletedDecember 15, 2022
December 1, 2022
4 months
April 22, 2021
December 14, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Amplitude of gustatory evoked potentials
After a fasting period of 2 hours
Latency of the gustatory evoked potential
After a fasting period of 2 hours
Study Arms (3)
Major Cognitive Impairment
EXPERIMENTALMinor Cognitive Impairment
EXPERIMENTALNo Cognitive Impairment
ACTIVE COMPARATORInterventions
Fasting blood glucose, dosage of acylated and non-acylated ghrelin, leptin, insulin and serotonin.
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
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.
Recording of gustatory evoked potentials
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Dijon Bourgogne
Dijon, 21000, France
Related Publications (1)
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.
PMID: 38007646DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2021
First Posted
April 27, 2021
Study Start
March 3, 2021
Primary Completion
June 17, 2021
Study Completion
June 17, 2021
Last Updated
December 15, 2022
Record last verified: 2022-12