The Effects of Rosiglitazone in Patients with MCI

罗格列酮对 MCI 患者的影响

• 批准号: 6985676
• 负责人: SUZANNE CRAFT
• 金额: $ 47.11万
• 依托单位: SEATTLE INST FOR BIOMEDICAL/CLINICAL RES
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6985676
• 关键词: Alzheimer' s disease; behavioral /social science research tag; blood tests; brain disorder chemotherapy; clinical research; clinical trials; cognition disorders; disease /disorder prevention /control; disease /therapy duration; enzyme linked immunosorbent assay; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; inflammation; insulin sensitivity /resistance; longitudinal human study; magnetic resonance imaging; mass spectrometry; memory disorders; neuropsychological tests; peroxisome proliferator activated receptor; rosiglitazone; temporal lobe /cortex disorder; urinalysis; western blottings

DESCRIPTION (provided by applicant): The proposed placebo-controlled clinical trial will test the hypothesis that rosiglitazone, a peroxisome proliferator-activated receptor-gamma (PPAR-gamma) agonist with insulin-sensitizing and anti-inflammatory properties, improves memory in persons with amnestic mild cognitive impairment (MCI). One hundred participants will be randomly assigned to receive 18 months of treatment with rosiglitazone or placebo, with cognitive assessment at 6 month intervals. They will also undergo serial structural magnetic resonance imaging (MRI) prior to and at the end of treatment to determine whether rosiglitazone ameliorates the rate of atrophy in medial temporal lobe (MTL) structures supporting memory. A subset of participants will receive lumbar punctures before and following treatment to determine whether rosiglitazone affects cerebrospinal fluid (CSF) levels of biomarkers associated with AD. This trial will provide valuable data regarding the effects of improved insulin sensitivity, reduced peripheral insulin levels, and reduced inflammation on cognitive function and biological markers in amnestic MCI, a likely prodromal phase of Alzheimer's disease (AD). Most importantly, this trial will elucidate the feasibility and potential efficacy of a novel treatment that may prevent or postpone the onset of AD. In doing so, we will lay the groundwork for future full-scale clinical trials of PPAR-gamma, agonists.

描述（由申请人提供）：拟议的安慰剂对照临床试验将检验以下假设：罗马列酮是一种过氧化物酶体增殖物激活的受体伽马（PPAR-GAMMA）激动剂，具有胰岛素敏感性和抗炎特性，可改善具有敏感性的敏感性认知能力（MCI）的记忆。一百名参与者将被随机分配接受长litazone或安慰剂的18个月治疗，并以6个月的间隔进行认知评估。他们还将在治疗之前和结束前进行串行结构磁共振成像（MRI），以确定罗格列酮是否可以改善支持记忆的内侧颞叶（MTL）结构中萎缩的速率。参与者的一部分将在治疗前后接受腰椎穿刺，以确定罗格列酮是否影响与AD相关的生物标志物的脑脊液（CSF）水平。该试验将提供有关改善胰岛素敏感性，降低外周胰岛素水平以及炎症对Amnestic MCI认知功能和生物学标记的炎症的有价值的数据，Amnestic MCI可能是阿尔茨海默氏病（AD）的前驱阶段。最重要的是，该试验将阐明一种新型治疗方法的可行性和潜在功效，该治疗方法可能阻止或推迟AD发作。在此过程中，我们将为PPAR-Gamma（激动剂）的未来全尺度临床试验奠定基础。