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通过分析味觉诱发电位,对患有轻微或主要认知障碍(如阿尔茨海默氏症)的患者进行味觉前瞻性单中心研究。 (MAPEG)

2026年10月2日 更新者:Centre Hospitalier Universitaire Dijon

通过分析味觉诱发电位,对患有轻微或主要认知障碍(如阿尔茨海默氏症)的患者进行味觉前瞻性单中心研究

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.

研究概览

研究类型

介入性

注册 (实际的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Dijon、法国、21000
        • Chu Dijon Bourgogne

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:主要认知障碍

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

实验性的:轻微认知障碍

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

有源比较器:无认知障碍

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

研究衡量的是什么?

主要结果指标

结果测量
大体时间
味觉诱发电位的幅度
大体时间:禁食 2 小时后
禁食 2 小时后
味觉诱发电位的潜伏期
大体时间:禁食 2 小时后
禁食 2 小时后

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月3日

初级完成 (实际的)

2021年6月17日

研究完成 (实际的)

2021年6月17日

研究注册日期

首次提交

2021年4月22日

首先提交符合 QC 标准的

2021年4月22日

首次发布 (实际的)

2021年4月27日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月2日

最后验证

2022年12月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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