文摘
摘要目的:评估Allopregnanolone大脑结构和连通性的影响。
背景:鉴于海马体积的成像生物标志物预测认知衰退本身虽然不是一个测量的认知,我们建议使用它作为一个代理端点检测的有效性allopregnanolone作为温和的再生治疗的广告。
设计/方法:一个多中心、双盲、随机对照的临床试验。共有200名参与者与温和的广告,100名参与者每次治疗手臂,将登记。合格的参与者是男性还是女性,55 - 80岁,被诊断为可能的广告,MMSE 20-26和APOEɛ4运营商。研究干预allopregnanolone 4毫克(管理静脉注射超过30分钟,每周)或匹配的安慰剂,1:1的分配,在十二个月内。12个月后,所有的参与者在安慰剂组将跨越为6个月收到allopregnanolone开放阶段。大脑成像评价主要终点将进行基线,6和12个月。所有成像站点参与审判将彻底评估,必须有足够的能力执行基本的和先进的核磁共振序列所需的协议。
结果:主要终点是指在海马体积变化率12个月。次级终点包括认知结果平均变化率(CANTAB-PAL ADAS-Cog11)、功能(ADCS-iADL)和安全结果在12个月。探索性端点包括1)区域脑容量,白质纤维束扩散措施,平均内在连接,和脑血流量;2)blood-based目标接触的生物标志物;3)其他临床结果(CDR-SB ADAS-Cog14, MMSE、NPI-Q EQ-5D-5L健康相关生活质量量表,QoL-AD, Zarit负担访谈问卷在12至18个月;4)从基线变化开放治疗所有端点的参与者。
结论:从本研究的结果将验证之前的研究结果表明allopregnanolone可能起到再生和神经保护作用在阿尔茨海默氏症的大脑结构和连接。
披露:埃尔南德斯博士里维拉的机构已经收到国家衰老研究院的研究支持。埃尔南德斯博士里维拉的机构已经收到国家衰老研究院的研究支持。洛佩兹太太没有披露。这位博士没有披露。凯瑟琳·罗杰斯已经收到个人薪酬在500 - 4999美元的范围为Proneurogen担任顾问。凯瑟琳·罗杰斯已经收到个人补偿的范围0 - 499美元为科学顾问或服务数据安全监测委员会Regulonix。凯瑟琳·罗杰斯已经收到知识产权利益从发现或技术有关卫生保健。黎明马修斯已收到个人赔偿ADM诊断作为一个员工,Inc .黎明马修斯收到了股票或ADM诊断公司的所有权。黎明马修斯的机构已经收到了来自美国国立卫生研究院的研究支持。施耐德博士已经收到个人薪酬在500 - 4999美元的范围为AC Immue担任顾问。施耐德博士已经收到个人薪酬在500 - 4999美元的范围为Biovie担任顾问。 Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Athira. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alpha-cognition. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Corium. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cortexyme. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurim Ltd. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Otsuka. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. The institution of Dr. Schneider has received research support from NIH. The institution of Dr. Schneider has received research support from Eli Lilly. The institution of Dr. Schneider has received research support from Biogen. The institution of Dr. Schneider has received research support from Biohaven. Roberta Diaz Brinton, PhD has nothing to disclose.
