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（由申请人提供）：这是NIH资助申请1 R 01 AG 025515 -01的修订版，GHRH：衰老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年美元）。在阿尔茨海默病过程中尽早识别和治疗个体的必要性是明确的，并且证明了加强对轻度认知障碍（MCI）个体的研究是合理的，这些个体在几年内有进展为痴呆症的风险。FDA最近关于MCI作为药物治疗适应症的听证会是其作为公共卫生问题的重要性的主要指标。文献中有大量令人信服的证据表明，促生长激素（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益影响。补充生长激素轴可能对个体有直接益处，例如MCI患者，他们正在经历轻度但显著的认知障碍，并且可能处于持续认知下降和进展为AD的特定风险中。 我们最近表明，为期五个月的生长激素释放激素（GHRH）治疗可改善健康老年男性和女性的认知功能，初步证据支持MCI患者的预期类似效果。我们认为，重要的是要复制和显着扩展我们最初的GHRH发现在健康的老年人，使用更全面的认知评估电池，其中包括记忆的措施不包括在我们的初步研究。我们还认为，将我们对GHRH认知功能增强作用的研究扩展到MCI老年人样本至关重要。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名健康正常老年男性和女性以及80名诊断为MCI的老年男性和女性认知功能的影响。