An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Serum Phospholipids and Fatty Acid Profile
研究概览
简要总结
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population
详细描述
The main objective of the current Asian nutritional status study is to get more insight into the nutritional status of AD patients in an Asian population in Asia. Plasma levels of several micronutrients and the fatty acid profile will be compared between patients with mild and moderate AD and cognitively intact healthy controls in an Asian population
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 years old
- •Asian ethnicity
- •Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating Scale for Geriatrics rating of ≤ 2 for all categories except for the category "psychiatric illness" which should have a rating of 0 and a CDR of 0 within 1 year prior to the visit.
- •Group 2a: AD patients clinically diagnosed with mild AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1
- •Group 2b: AD patients clinically diagnosed with moderate AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-2
- •Written informed consent provided according to local regulations.
排除标准
- •Group 1 only: Current diagnosis of AD or other dementias according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al.,1984 )
- •Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g. donepezil, rivastigmine, galantamine or memantine)
- •Group 1 and 2:
- •Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD), including vascular dementia according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria, cerebral tumour, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, seizures, major depression, schizophrenia and other entities
- •Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3 months prior to the visit
- •Use of vitamin B injections
- •Alcohol or drug abuse as per investigator's judgement
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
结局指标
主要结局
Serum Phospholipids and Fatty Acid Profile
时间窗: 1 day
Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood
Uridine
时间窗: 1 day
To look at nutritional Status in the blood
Homocysteine
时间窗: 1 day
To look at nutritional Status in the blood
Vitamin E
时间窗: 1 day
To look at nutritional Status in the blood
Plasma polar lipid profile
时间窗: 1 day
Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters To look at nutritional Status in the blood
Red Blood Cell Phospholipids and fatty acid profile
时间窗: 1 day
Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood
Choline
时间窗: 1 day
To look at nutritional Status in the blood
Kidney function - Creatinine
时间窗: 1 day
Other blood parameters
Vitamin B12
时间窗: 1 day
To look at nutritional Status in the blood
Inflammatory marker
时间窗: 1 day
C-reactive protein analysed using high sensitive C-reactive protein
Vitamin B6
时间窗: 1 day
To look at nutritional Status in the blood
Folate
时间窗: 1 day
To look at nutritional Status in the blood
Selenium
时间窗: 1 day
To look at nutritional Status in the blood
Vitamin D
时间窗: 1 day
To look at nutritional Status in the blood
HbA1C (haemoglobin A1C )
时间窗: 1 day
Other blood parameters
Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase
时间窗: 1 day
Other blood parameters
次要结局
未报告次要终点