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: 7125967
• 负责人: MICHAEL V. VITIELLO
• 金额: $ 50.73万
• 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 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7125967
• 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（由申请人提供）：这是NIH赠款申请1 R01 AG025515-01，GHRH：衰老和轻度认知障碍的认知。 阿尔茨海默氏病（AD）和其他原发性神经退行性痴呆症的社会负担是巨大的，美国每年的年总成本估计为1000亿美元（1996年）。在阿尔茨海默氏病过程中尽早识别和治疗个体的需求是明确的，并证明对在几年内有进展到痴呆症风险的轻度认知障碍（MCI）的研究的加强是合理的。 FDA最近关于MCI作为药物疗法的适用性的听证会是其重要性的主要指标。在文献中有很大的证据表明，母营养（生长激素释放激素/生长激素/胰岛素样生长因子I）激素轴对认知功能具有显着且可预测的有益影响。补充营养轴可能会对患有MCI的人（例如患有轻度但严重的认知障碍，并且可能持续持续认知下降和发展为AD的人）有直接的好处。 我们最近表明，五个月的生长激素释放激素（GHRH）治疗可改善健康的老年男性和女性的认知功能，而初步证据则支持对MCI患者的相似作用的期望。我们认为，使用更全面的认知评估电池，复制并显着扩展了健康老年人最初的GHRH发现，其中包括我们初步研究中未包括的记忆措施。我们还认为，将对GHRH的认知功能增强作用的检查扩展到MCI的老年人样本至关重要。因此，我们建议对GHRH对80位健康正常老年男女的认知功能以及80名被诊断出患有MCI的年龄较大的老年男性和女性进行一项前瞻性，双盲，随机的安慰剂对照研究。