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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Gustatory evoked potentials latency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control subjects
干预措施: Blood samples (Biological)
Control subjects
干预措施: Interviewing the subject and scales (Other)
Control subjects
干预措施: Neurocognitive evaluation (Other)
Control subjects
干预措施: Taste tests (Other)
Control subjects
干预措施: Computerized food preference questionnaires (Other)
Control subjects
干预措施: Nutritional status - body composition (Other)
Subjects with an isolated cognitive complaint
干预措施: Blood samples (Biological)
Subjects with an isolated cognitive complaint
干预措施: Interviewing the subject and scales (Other)
Subjects with an isolated cognitive complaint
干预措施: Neurocognitive evaluation (Other)
Subjects with an isolated cognitive complaint
干预措施: Taste tests (Other)
Subjects with an isolated cognitive complaint
干预措施: Computerized food preference questionnaires (Other)
Subjects with an isolated cognitive complaint
干预措施: Nutritional status - body composition (Other)
Subjects with minor neurocognitive disorders
干预措施: Blood samples (Biological)
Subjects with minor neurocognitive disorders
干预措施: Interviewing the subject and scales (Other)
Subjects with minor neurocognitive disorders
干预措施: Neurocognitive evaluation (Other)
Subjects with minor neurocognitive disorders
干预措施: Taste tests (Other)
Subjects with minor neurocognitive disorders
干预措施: Computerized food preference questionnaires (Other)
Subjects with minor neurocognitive disorders
干预措施: Nutritional status - body composition (Other)
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
干预措施: Blood samples (Biological)
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
干预措施: Interviewing the subject and scales (Other)
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
干预措施: Neurocognitive evaluation (Other)
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
干预措施: Taste tests (Other)
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
干预措施: Computerized food preference questionnaires (Other)
Subjects with major neurocognitive disorders of the mild to moderate Alzheimer's disease type
干预措施: Nutritional status - body composition (Other)
结局指标
主要结局
Gustatory evoked potentials latency
时间窗: After a 2-hour fasting period
Amplitude of the gustatory evoked potentials
时间窗: After a 2-hour fasting period
次要结局
未报告次要终点