HIGH DOSE SUPPLEMENTS TO REDUCE HOMOCYSTEINE IN ALZHEIMER'S DISEASE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 有强有力的证据表明，相对较高的同型半胱氨酸水平与阿尔茨海默病有关，并可能通过导致血管和神经元损伤而促进疾病的病理生理学。高剂量的叶酸、维生素B6和B12补充剂可以降低同型半胱氨酸水平。 这是一项平行设计的随机对照研究，包括两组不同大小的受试者：60%的受试者将每天服用高剂量补充剂(叶酸5毫克、维生素B6 25毫克和维生素B12 1毫克)，40%的受试者将接受相同的安慰剂。400名被诊断为阿尔茨海默病的受试者将参加这项试验，该网站招募了大约10名受试者。参与者将接受为期18个月的治疗，每三个月进行一次认知、行为和临床评估。参加者必须由一名“学习伙伴”陪同参观。 主要的结果衡量标准将是ADAScog评分的纵向下降。次要结果测量包括CDR盒子总和、ADCS日常生活能力、药物经济学量表、生活质量-AD和神经精神病学问卷。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There is strong evidence that relatively high homocysteine levels are associated with Alzheimer's disease, and may contribute to disease pathophysiology by causing vascular and neuronal damage. Homocysteine levels can be reduced by administration of high dose supplements of folic acid, vitamins B6 and B12. This is a parallel design, randomized controlled study with two groups of unequal size: 60% of participants will receive daily high dose supplements (folic acid 5mg, vitamin B6 25mg and B12 1 mg), and 40% will receive identical placebo. 400 subjects with a diagnosis of AD will be enrolled in the trial with approximately 10 subjects recruited at this site. Participants will be treated with this regime for a total of 18 months with cognitive, behavioral and clinical assessments done every three months. Participants must be accompanied by a "study partner" to the visits. The primary outcome measure will be the longitudinal decline in the ADAScog score. Secondary outcome measures include the CDR sum of boxes, ADCS Activities of Daily Living, Pharmacoeconomic scales, the Quality of Life-AD and the Neuropsychiatry Inventory.