MIND DIET AND DEMENTIA PREVENTION IN ISCHEMIC STROKE PATIENTS

项目负责人/主要研究者（最后，第一，中间）：Morris，Martha克莱尔和Aggarwal，Neelum T 这是R 01申请AG 062637的重新提交，其标题为“MIND饮食和痴呆症预防， 缺血性中风患者。”该申请是一项III期随机对照试验，旨在测试效果 MIND饮食加常规卒中后护理与常规卒中后护理的3年干预对认知功能的影响 下降，AD和血管疾病的脑生物标志物，以及500例功能障碍和抑郁症 因急性缺血性卒中住院的患者，年龄60-80岁，出院时无痴呆 住院后回家。在美国，每年有超过795，000人中风，其中大多数人都是中风患者。 其中87%是缺血性的。估计每年的费用为340亿美元。中风是导致严重 长期残疾。据估计，大约一半的幸存者将经历认知障碍， 抑郁症，三分之一将发展为中风后痴呆症。痴呆症是一个主要的和不断增长的公共卫生 由于缺乏有效的治愈或疗法来改善疾病进展而放大的问题， 症状生活方式的改变，包括使用DASH和地中海饮食的饮食干预， 已被证明可以保持或改善老年人的认知功能和抑郁症， 然而，对于心血管风险，饮食是否是中风的有效治疗干预尚不清楚。 幸存者重要的是，饮食建议是中风患者及其家属非常期望的。的 MIND饮食（Mediterranean DASH干预神经退行性延迟）是地中海饮食的混合体。 和DASH饮食，但根据对大脑健康重要的食物和营养素进行选择性修改。 MIND饮食具有与DASH和地中海饮食相同的基本成分，例如强调 天然植物性食品和有限的动物性和高饱和脂肪食品，但独特地指定绿色多叶 蔬菜和浆果以及反映营养痴呆证据的食物成分。的 试验将采用平行组设计，比较MIND干预的效果（3个月的分娩）。 MIND餐，随后进行饮食咨询）与常规卒中后护理（3个月的交付自选 餐后进行一般中风健康咨询）对认知功能和功能能力下降的影响， 和抑郁症状。MIND饮食的生物效应将通过以下指标的变化来评估： 视网膜成像衍生的淀粉样β斑块积聚，以及MRI衍生的脑宏观和微观结构 300名随机选择的参与者。将在治疗期间评估其他生化标志物 在整个500名参与者的队列中，包括：血浆Abeta 42/Abeta 40，脑源性神经营养因子 脑源性神经营养因子（BDNF）和氧化应激和炎症的血浆标志物。此外，审判将审查 潜在的效应介质和调节剂的心血管危险因素，AD生物标志物，和 生物机制。这项研究在综合性卒中中心有三个招募点， 芝加哥和拉什大学的一个临床研究中心。 PHS 398/2590（Rev.06/09）

Program Director/Principal Investigator (Last, First, Middle): Morris, Martha Clare and Aggarwal, Neelum T This is a resubmission of R01 application AG062637 that is retitled to, “MIND Diet and Dementia Prevention in Ischemic Stroke Patients.” The application is a Phase III randomized-controlled trial designed to test the effects of a 3-year intervention of the MIND diet plus usual post-stroke care versus usual post-stroke care on cognitive decline, brain biomarkers of AD and vascular disease, and on functional disability and depression in 500 patients hospitalized for acute ischemic stroke, aged 60-80 years and without dementia who are discharged home following hospitalization. More than 795,000 people in the U.S. have a stroke every year, the majority of which (87%) are ischemic. The estimated cost is $34 billion each year. Stroke is the leading cause of serious long-term disability. It is estimated that about half of survivors will experience cognitive impairment and depression, and one third will develop post-stroke dementia. Dementia is a major and growing public health problem that is amplified by the lack of effective cures or therapies to ameliorate the disease progression and symptoms. Lifestyle modifications, including dietary interventions using the DASH and Mediterranean diets, have been demonstrated to preserve or improve cognitive function and depression in older adults at high cardiovascular risk, however, it is unknown whether diet is an effective therapeutic intervention in stroke survivors. Importantly, dietary recommendations are highly desired by stroke patients and their families. The MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) is a hybrid of the Mediterranean and DASH diets but with selected modifications based on foods and nutrients that are important to brain health. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant-based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition-dementia evidence. The trial will employ a parallel group design comparing the effects of the MIND intervention (3 months of delivered MIND meals followed by dietary counseling) versus usual post-stroke care (3 months of delivered self-selected meals followed by general stroke health counseling) on decline in cognitive function and functional abilities, and depressive symptoms. Biological effects of the MIND diet will be assessed by change in measures of retinal imaging-derived amyloid beta plaque accumulation, and MRI-derived brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed over the treatment period in the entire cohort of 500 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, the trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers, and biological mechanisms. The proposed study has three recruitment sites at comprehensive stroke centers in Chicago and one clinical site at Rush University. PHS 398/2590 (Rev. 06/09) Page Continuation Format Page