GHRH: COGNITION IN AGING AND MILD COGNITIVE IMPAIRMENT

GHRH：衰老和轻度认知障碍中的认知

• 批准号: 6975324
• 负责人: MICHAEL V. VITIELLO
• 金额: $ 50.95万
• 依托单位: UNIVERSITY OF WASHINGTON
• 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 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6975324
• 关键词: behavior test; behavioral /social science research tag; biomarker; blood tests; brain disorder chemotherapy; clinical research; clinical trials; cognition disorders; growth hormone releasing hormone; hormone therapy; human old age (65+); human subject; human therapy evaluation; insulinlike growth factor; interview; neuropsychological tests

DESCRIPTION (provided by applicant): This is a revision of NIH grant application 1 R01 AG025515-01, GHRH: Cognition in Aging and Mild Cognitive Impairment. The societal burden of Alzheimer's disease (AD) and other primary neurodegenerative dementias is monumental, with total annual costs estimated at $100 billion (1996 dollars) per year in the United States. The need to identify and treat individuals as early as possible in the Alzheimer's disease process is clear, and justifies intensification of studies of individuals with Mild Cognitive Impairment (MCI) who are at risk for progression to dementia within a few years. The FDA's recent hearings on the suitability of MCI as an indication for pharmacotherapy are major indicators of its importance as a public health concern. There is considerable and compelling evidence in the literature that the actions of the somatotrophic (growth hormone releasing hormone/ growth hormone/insulin-like growth factor I) hormonal axis have significant and predictable beneficial impact on cognitive function. Supplementation of the somatotrophic axis may likely be of direct benefit to individuals such as those with MCI, who are experiencing a mild but significant cognitive impairment and who may be at particular risk for continued cognitive decline and progression into AD. We have recently shown that a five-month growth hormone releasing hormone (GHRH) treatment improves cognitive function in healthy older men and women and preliminary evidence supports the expectation of a similar effect in individuals with MCI. We believe it important to replicate and significantly extend our initial GHRH finding in healthy older adults, using a much more comprehensive cognitive assessment battery, which includes measures of memory not included in our preliminary study. We also believe it crucial to extend our examination of the cognitive function enhancing effects of GHRH to a sample of older adults with MCI. Therefore we propose to conduct a prospective, double-blind, randomized placebo-controlled study of the effects of GHRH on the cognitive function of 80 healthy normal older men and women and of 80 older men and women diagnosed with MCI.

描述(申请人提供)：这是NIH拨款申请的修订版1 R01 AG025515-01，GHRH：老化和轻度认知障碍中的认知。 阿尔茨海默病(AD)和其他原发性神经退行性痴呆的社会负担是巨大的，在美国，每年的总成本估计为1000亿美元(1996美元)。在阿尔茨海默病过程中尽早识别和治疗个体的必要性是显而易见的，因此有理由加强对轻度认知障碍(MCI)患者的研究，这些患者有可能在几年内发展为痴呆症。FDA最近就MCI作为药物治疗适应症的适宜性举行的听证会是其作为公共卫生问题重要性的主要指标。有相当多和令人信服的证据表明，生长激素(生长激素释放激素/生长激素/胰岛素样生长因子I)激素轴的作用对认知功能具有显著和可预测的有利影响。补充生长营养轴可能对像MCI患者这样的人有直接的好处，这些人正在经历轻微但严重的认知损害，他们可能处于持续认知下降和进展为AD的特别风险中。 我们最近表明，为期五个月的生长激素释放激素(GHRH)治疗可以改善健康老年男性和女性的认知功能，初步证据支持对MCI患者具有类似效果的预期。我们认为，重要的是复制并显著扩展我们在健康老年人中的初步GHRH发现，使用更全面的认知评估单元，其中包括我们初步研究中未包括的记忆测量。我们还认为，将我们对GHRH认知功能增强效应的研究扩展到患有MCI的老年人样本是至关重要的。因此，我们建议进行一项前瞻性、双盲、随机、安慰剂对照研究，研究GHRH对80名健康的正常老年男性和女性以及80名确诊为MCI的老年男性和女性认知功能的影响。