NL-OMON24193已完成不适用
The Effect of a Nutritional Intervention on brain Glucose Metabolism in early Alzheimer's disease
VU University Medical Center0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Scheltens NME, Kuyper IS, Boellaard R, Barkhof F, Teunissen CE, Broersen LM, Lansbergen MM, Van der Flier WM, Van Berckel BNM, Scheltens Ph. Design of the NL-ENIGMA study: Exploring the effect of Souvenaid on cerebral glucose metabolism in early Alzheimer's disease. Alzheimers Dement: TR & CI, 2016 (223-240). Scheltens NME & Briels CT, Yacub M, Barkhof F, Boellaard R, Van der Flier WM, Schwarte LA, Teunissen CE, Attali A, Broersen LM, Van Berckel BNM & Scheltens P. Exploring effects of Souvenaid on cerebral glucose metabolism in Alzheimer’s disease. Alzheimers Dement: TR & CI, 2019 (492-500).
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Change in inclusion criteria 15-04-2016:
- •Subjects diagnosed with MCI due to AD according to the criteria from the National Institute on Aging and the Alzheimer’s Association (NIA-AA) (Albert et al., Alzheimer's & Dementia. 2011;7:270-279) or diagnosed as having mild dementia due to AD according to the NIA-AA criteria (McKhann et al., Alzheimer’s & Dementia. 2011; 7:263–269).
排除标准
- •Diagnosis of significant neurological and / or psychiatric disease other than AD, including vascular dementia according to NINDS-AIREN criteria, cerebral tumour, Huntington’s disease, Parkinson’s disease, normal pressure hydrocephalus (NPH), seizures, delirium, schizophrenia, major depression and other entities relevant for brain function.
- •Diagnosis of diabetes or use of anti-diabetic medication. Non-fastening blood glucose concentration ≥ 10.0 mmol/l at screening is an exclusion criterion, unless blood glucose concentration is < 7.0 mmol/l when measurement is repeated when patient is in fasting state.
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