MIND DIET AND DEMENTIA PREVENTION IN ISCHEMIC STROKE PATIENTS

项目主任/首席调查员(最后、第一、中间)：Morris，Martha Clare和Aggarwal，Neelum T 这是R01申请AG062637的重新提交，该申请被重新命名为“精神饮食和痴呆症预防 缺血性中风患者。“该应用是一项旨在测试疗效的第三阶段随机对照试验 为期3年的心理饮食干预加常规卒中后护理与常规卒中后护理对认知功能的影响 阿尔茨海默病和血管疾病的脑生物标志物，以及功能障碍和抑郁在500人中的下降 急性缺血性卒中住院患者，年龄60-80岁，无痴呆，出院 住院后回家。在美国，每年有超过79.5万人中风，其中大多数 其中(87%)为缺血。据估计，每年的成本为340亿美元。中风是导致严重中风的主要原因 长期残疾。据估计，大约一半的幸存者将经历认知障碍和 抑郁症，三分之一会患中风后痴呆症。痴呆症是一种重大且日益严重的公共卫生问题 由于缺乏有效的治疗方法或治疗方法来改善疾病的进展和 症状。改变生活方式，包括使用DASH和地中海饮食的饮食干预， 已被证明可以保护或改善老年人的认知功能和抑郁 然而，饮食是否是中风的有效治疗干预措施尚不清楚。 幸存者。重要的是，中风患者和他们的家人非常希望得到饮食建议。这个 心灵饮食(地中海式神经退行性延迟干预疗法)是地中海式饮食的混合体 和DASH饮食，但根据对大脑健康重要的食物和营养素进行精选的修改。 Mind饮食与Dash和地中海饮食具有相同的基本成分，例如强调 天然植物性食品、限量动物食品和高饱和脂肪食品，但仅限于绿叶食品 蔬菜和浆果以及反映营养-痴呆症证据的食物成分服务。这个 试验将采用平行分组设计，比较心理干预(分娩3个月)的效果 精神餐后饮食咨询)与通常的中风后护理(3个月自行选择的分娩 进餐后进行一般中风健康咨询)认知功能和功能能力下降， 和抑郁症状。智力饮食的生物学效应将通过改变以下指标来评估 视网膜成像衍生的淀粉样β斑块堆积和磁共振衍生的大脑宏观和微观结构 对300名随机选择的参与者进行了诚信测试。其他生化标志物将在治疗过程中进行评估 在500名参与者的整个队列中的时间段，包括：血浆Abeta 42/Abeta 40，脑源性神经营养 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 一些心血管危险因子、AD生物标志物和 生物机制。这项拟议的研究在年综合中风中心有三个招聘地点 芝加哥和拉什大学的一个临床站点。 PHS 398/2590(06/09版)页面续格式页面

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