上海NAIII期临床试验-一项在具有认知和功能衰退风险的早期阿尔茨海默病受试者中比较remternetug与安慰剂的研究

登记号	CTR20250052	试验状态	进行中
申请人联系人	王秀秀	首次公示信息日期	2025-01-09
申请人名称	Eli Lilly and Company/ 礼来苏州制药有限公司/ Catalent Indiana, LLC

登记号	CTR20250052
相关登记号	暂无
药物名称	NA
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	早期阿尔茨海默病
试验专业题目	早期阿尔茨海默病中Remternetug研究
试验通俗题目	一项在具有认知和功能衰退风险的早期阿尔茨海默病受试者中比较remternetug与安慰剂的研究
试验方案编号	J1G-MC-LAKI	方案最新版本号	J1G-MC-LAKI 初始方案
版本日期:	2024-06-28	方案是否为联合用药	否

申请人名称	[["Eli Lilly and Company"],["礼来苏州制药有限公司"],["Catalent Indiana, LLC"]]
联系人姓名	王秀秀	联系人座机	010-59042142	联系人手机号	19602105058
联系人Email	wang_xiu_xiu@lilly.com	联系人邮政地址	上海市-上海市-静安区石门一路288号兴业太古汇1座19楼	联系人邮编	200041

在早期AD受试者中评估remternetug与安慰剂相比，对至有临床意义的疾病进展的时间的影响。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	55岁(最小年龄)至 80岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["能够提供并已签署知情同意（如附录1第10.1.3 节所述），其中包括遵守ICF和本方案中列出的要求和限制。"],["签署ICF时年龄为55（含）至80岁（含）。"],["静脉通路满足方案采血要求。"],["在筛选时，经研究者判断，具备足够的读写和视听能力，可以进行神经心理学测试。"],["愿意并有能力在研究过程中持续可靠地参加，愿意遵循研究程序，包括使用电子设备以完成研究相关问卷和视频通话。"],["有至少1名达到下列所有标准的可靠研究伙伴： n1.达到参加研究知情同意的法定年龄n2.已提供自己的书面知情同意，并能够遵守ICF和本方案中列出的要求n3.与受试者经常联系，熟悉受试者总体的功能和行为，例如日常活动和认知能力n4.在家进行SC注射时可予以监督，并愿意和能够进行注射（如需要），以及n5.能够完成需要研究伙伴的研究评估。n可另选一名研究伙伴作为备选。如果一名研究伙伴必须退出研究，更换符合资格的研究伙伴时必须得到研究者的确认和批准。在开始任何研究活动之前，替代的研究伙伴需要提供自己的书面知情同意。"],["访视601时的血浆P-tau结果与存在异常脑淀粉样蛋白病理一致。"],["访视1时MMSE评分≥27分。"],["访视1时FAQ评分<6分。"],["如果目前正在接受药物作为AD的对症治疗（例如胆碱酯酶抑制剂），那么在访视1前给药剂量已稳定至少30天，并计划在研究期间保持剂量稳定。"]]
排除标准	[["患有痴呆或其他会影响认知的重大神经系统疾病。"],["目前存在严重或不稳定的疾病，包括心血管、肝、肾、胃肠、呼吸、内分泌、神经（AD除外）、精神、免疫或血液系统疾病以及研究者认为可能干扰本研究分析的其他情况；或预期寿命大约≤5年。"],["存在研究者认为复发风险高并妨碍研究完成的癌症病史"],["存在以下任何一种情况：n1.对C-SSRS“自杀意念”部分中问题4或问题5的回答为“是”，且在过去1个月内出现过自杀意念，或n2.对C-SSRS“自杀行为”部分中任何一项自杀相关行为的回答为“是”，且在过去1个月内出现过自杀行为。"],["具有临床显著意义的多发性或严重药物过敏、明显的特应性过敏体质或严重的治疗后超敏反应（包括但不限于重型多形性红斑、线形IgA皮肤病、中毒性表皮坏死松解症和/或剥脱性皮炎）病史。"],["筛选/基线时，存在由研究者确定的可能对受试者有害或可能影响研究的有临床意义的生命体征、ECG、临床实验室检查结果、体格检查或MRI的重要异常。"],["筛选时有1个或多个以下实验室检查结果：n1. ALT ≥2.5×ULNn2. AST ≥2.5×ULNn3. TBL ≥1.5×ULNn4. ALP ≥2×ULNn注：TBL≥1.5×ULN的受试者，如果符合Gilbert’s综合征的以下所有标准，则不予排除：n5. 筛选时胆红素以间接胆红素（未结合）为主（直接胆红素在正常范围内）。n6. 无肝脏疾病。n7. 筛选时ALT、AST和ALP均≤1×ULN。n8. 筛选时血红蛋白没有显著降低。"],["存在任何MRI禁忌症，包括幽闭恐惧症，或存在与MRI不兼容的禁用金属（铁磁性）植入物/心脏起搏器，或无法使用到有起搏器患者可使用的MRI设备。"],["筛选时MRI中心阅片显示存在ARIA-E，>4处脑微出血，任何脑皮质表面铁沉积，任何脑出血或严重脑白质病变。"],["曾接受过抗淀粉样蛋白被动免疫治疗，距访视1 <5个半衰期。"],["在其他研究中接受过针对Aβ的主动免疫治疗。"],["已知对remternetug、相关化合物或制剂中的任何成分过敏，如IB中所述。"],["目前正在参加任何其他医学研究（干预性或观察性），经科学或医学判断，不宜参加本研究。"],["在访视1前30天内参加过临床试验，其研究药物基于科学或医学判断，不宜进行研究LAKI。如果既往使用的研究药物在科学上或医学上不宜再进行研究LAKI，则受试者在参加研究LAKI筛选前应经过至少3个月或5个半衰期的间隔期（以较长者为准）。在审查观察性研究的方案并获得申办方批准后，可允许近期参加观察性研究的受试者。"],["既往已接受随机分组治疗并完成本研究或退出本研究，或者在本研究或任何既往临床研究中接受过remternetug给药。"],["有潜在生育能力，定义参见附录4，第10.4.1节。"],["目前妊娠或在哺乳，或者计划在本研究期间妊娠或哺乳"],["是直接参与本研究的研究中心工作人员或是其直系亲属。直系亲属是指配偶、父母、子女或兄弟姐妹，无论是生物学意义上的或法律上领养的亲属关系。"],["是直接参与本研究的礼来公司员工，或其研究伙伴是直接参与本研究的礼来公司员工"],["在开放标签扩展期首次给药前出现表面铁沉积的受试者。"],["在开放标签扩展期开始前出现不稳定的或严重的疾病，或根据研究者判断，不能接受remternetug治疗的受试者。"]]

试验药	[["中文通用名:NA 英文通用名:remternetug 商品名称:NA","剂型:注射用溶液 规格:400mg/2ml 用法用量:仅供皮下用药。在第0周（随机）和第8周给予400mg，然后在第16周、第24周、第32周，之后每4周一次，直至第72周（含），给予800mg共15次给药. 用药时程:在第0周（随机）和第8周给予400mg，然后在第16周、第24周、第32周，之后每4周一次，直至第72周（含），给予800mg共15次给药"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂 英文通用名:NA 商品名称:NA","剂型:注射用溶液 规格:400mg/2ml 用法用量:安慰剂成分：L-组氨酸、L-组氨酸盐酸盐一水合物、L-精氨酸盐酸盐、L-甲硫氨酸和聚山梨酯80。仅供皮下用药。在第0周（随机）和第8周给予400mg，然后在第16周、第24周、第32周，之后每4周一次，直至第72周（含），给予800mg共15次给药 用药时程:在第0周（随机）和第8周给予400mg，然后在第16周、第24周、第32周，之后每4周一次，直至第72周（含），给予800mg共15次给药"]] 序号 名称 用法

主要终点指标及评价时间	[["通过CDR测量的至有临床意义的疾病进展的时间。","双盲期结束时","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["受试者末次访视时，各临床结局评估结果较基线的变化","双盲期结束时","有效性指标"],["标准安全性评估，包括： n1. 自发报告的AE 2. 临床实验室检查 3. 生命体征和体重测量 4. MRI（ARIA和出现的影像学发现） 5. 超敏反应 6. 注射部位反应 7. C-SSRS","双盲期结束时","安全性指标"],["Remternetug的PK n抗remternetug TE ADA","第52周","有效性指标+安全性指标"],["以下血液生物标志物从基线至第104周的变化： n1. NfL n2. GFAP n3. P-tau","双盲期结束时","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	郁金泰	学位	博士研究生	职称	正高级
	电话	18678999982	Email	jintai_yu@fudan.edu.cn	邮政地址	上海市-上海市-乌鲁木齐中路12号
	邮编	200040	单位名称	复旦大学附属华山医院

[["复旦大学附属华山医院","郁金泰","中国","上海市","上海市"],["上海市第六人民医院","郭起浩","中国","上海市","上海市"],["浙江大学医学院附属邵逸夫医院","陈炜","中国","浙江省","杭州市"],["西安医学院第一附属医院","张蓓","中国","陕西省","西安市"],["吉林大学第一医院","孙莉","中国","吉林省","长春市"],["上海交通大学医学院附属仁济医院","徐群","中国","上海市","上海市"],["广州医科大学附属第二医院","刘军","中国","广东省","广州市"],["河南科技大学第一附属医院","杜敢琴","中国","河南省","洛阳市"],["南京脑科医院","许利刚","中国","江苏省","南京市"],["徐州医科大学附属医院","耿德勤","中国","江苏省","徐州市"],["自贡市第一人民医院","徐晓娅","中国","四川省","自贡市"],["上海市浦东新区人民医院","赵晓晖","中国","上海市","上海市"],["四川省人民医院","余能伟","中国","四川省","成都市"],["首都医科大学附属北京天坛医院","张巍","中国","北京市","北京市"],["河北医科大学第一医院","马晓伟","中国","河北省","石家庄市"],["四川大学华西医院","商慧芳","中国","四川省","成都市"],["延安大学咸阳医院","郭爱红","中国","陕西省","咸阳市"],["济南市中心医院","边红","中国","山东省","济南市"],["南京医科大学附属逸夫医院","鲁翔","中国","江苏省","南京市"],["南昌大学第二附属医院","唐震宇","中国","江西省","南昌市"],["徐州市中心医院","陈国芳","中国","江苏省","徐州市"],["中南大学湘雅医院","沈璐","中国","湖南省","长沙市"],["陕西省人民医院","李锐","中国","陕西省","西安市"],["南方医科大学珠江医院","郭洪波","中国","广东省","广州市"],["广东省人民医院","赵洁皓","中国","广东省","广州市"],["天津医科大学总医院","杨丽","中国","天津市","天津市"],["首都医科大学附属北京安定医院","张庆娥","中国","北京市","北京市"],["南昌大学第一附属医院","吴成斯","中国","江西省","南昌市"],["广州市第一人民医院","潘小平/陈浩博","中国","广东省","广州市"],["中国科学技术大学附属第一医院（安徽省立医院）","程昭昭 （施炯）","中国","安徽省","合肥市"],["苏州大学附属第二医院","刘春风","中国","江苏省","苏州市"],["Parkway Medical Center","James Sullivan","美国","Alabama","Birmingham"],["MD First Research - Chandler","Hemant Pandey","美国","Arizona","Chandler"],["Care Access - 801 South Power Road, Mesa","Donna DeSantis","美国","Arizona","Mesa"],["Banner Alzheimer's Institute","Po-Heng Tsai","美国","Arizona","Phoenix"],["Banner Alzheimer's Institute Tucson","Matthew Malone","美国","Arizona","Tucson"],["Neuro-Pain Medical Center","PERMINDER BHATIA","美国","California","Fresno"],["Care Access - Huntington Beach","Christine Thai","美国","California","Huntington Beach"],["Inglewood Clinical","Edward Zamrini","美国","California","Inglewood"],["Irvine Clinical Research","Elly Lee","美国","California","Irvine"],["Healthy Brain Clinic","Dung Trinh","美国","California","Long Beach"],["Riverside Clinical","Cydney Osano","美国","California","Riverside"],["Clinical Trials Research","Jeffrey Wayne","美国","California","Sacramento"],["Artemis Institute for Clinical Research","Eric Chavez","美国","California","San Diego"],["Sharp Neurocognitive Research Center","Paulette Cazares","美国","California","San Diego"],["Ray Dolby Brain Health Center","Armen Moughamian","美国","California","San Francisco"],["The Neuron Clinic - San Marcos","Jose Soria","美国","California","San Marcos"],["Syrentis Clinical Research","John Duffy","美国","California","Santa Ana"],["Providence Medical Foundation","Allan Bernstein","美国","California","Santa Rosa"],["California Neuroscience Research, LLC","Thomas Shiovitz","美国","California","Sherman Oaks"],["Care Access - Aurora","Mauricio Waintrub","美国","Colorado","Aurora"],["Tokyo Asbo Clinic","Akiyoshi Uchiyama","日本","Tokyo","Tokyo"],["Sakurazaka Clinic SophyAnce","Haruhito Muto","日本","Tokyo","Tokyo"],["Kanto Central Hospital","Akira Inaba","日本","Tokyo","Tokyo"],["Higashi Shinjuku Clinic","Hiroaki Kondo","日本","Tokyo","Tokyo"],["National Center for Geriatrics and Gerontology","Keisuke Suzuki","日本","Aichi","Obu"],["Medical Corporation Heishinkai OCROM Clinic","Satoshi Inoue","日本","Osaka","Suita-shi"],["Takatsuki Hospital","Hisatsugu Tachibana","日本","Osaka","Takatsuki-shi"],["Wako Hospital","Yukimichi Imai","日本","Saitama","Wako"],["Medical Corporation Chiseikai Tokyo Center Clinic","Hirotaka Nagashima","日本","Tokyo","Chuo-ku"],["Tokyo-Eki Center-building Clinic","Arihiro Kiyosue","日本","Tokyo","Chuo-ku"],["Fukuwa Clinic","Yasushi Fukushima","日本","Tokyo","Chuo-ku"],["P-One Clinic","Kenichi Furihata","日本","Tokyo","Hachioji"],["Tokyo Metropolitan Geriatric Hospital","Atsushi Iwata","日本","Tokyo","Itabashi"],["Heishinkai Medical Group ToCROM Clinic","Osamu Matsuoka","日本","Tokyo","Shinjuku-ku"],["Clinical Research Hospital Tokyo","Hiroyuki Fukase","日本","Tokyo","Shinjuku-ku"],["Samoncho Clinic","Takahiro Yokoyama","日本","Tokyo","Shinjuku-ku"],["Tachikawa Hospital","Hidenori Hattori","日本","Tokyo","Tachikawa"],["Chungbuk National University Hospital","Joon Hyung Jung","韩国","Chungcheongbuk-do [Chungbuk]","Cheongju-si"],["Inha University Hospital","Seong Hye Choi","韩国","Incheon-gwangyeoksi [Incheon]","Incheon"],["Gachon University Gil Medical Center","Kee Hyung Park","韩国","Incheon-gwangyeoksi [Incheon]","Namdong-gu"],["Jeju National University Hospital","JOON HYUK PARK","韩国","Jeju-teukbyeoljachido [Jeju]","Jeju-si"],["Wonju Severance Christian Hospital","Tae Hui Kim","韩国","Kang-won-do","Wonju"],["Chonnam National University Hospital","Byeong Chae Kim","韩国","Kwangju-Kwangyǒkshi","Gwangju-si"],["Seoul National University Bundang Hospital","Ji Won Han","韩国","Kyǒnggi-do","Seongnam"],["Ajou University Hospital","So Young Moon","韩国","Kyǒnggi-do","Suwon"],["Pusan National University Hospital","EUN JOO KIM","韩国","Pusan-Kwangyǒkshi","Busan"],["Gangnam Severance Hospital, Yonsei University Health System","Hanna Cho","韩国","Seoul-teukbyeolsi [Seoul]","Gangnam-gu"],["Ewha Womans University Seoul Hospital","Jee Hyang Jeong","韩国","Seoul-teukbyeolsi [Seoul]","Gangseo-gu"],["Seoul National University Hospital","BeLong Cho","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Seoul National University Hospital","Dong Young Lee","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Hanyang University Seoul Hospital","Hee-Jin Kim","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Konkuk University Medical Center","Seol-Heui Han","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Asan Medical Center","Hee-Won Jung","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Asan Medical Center","Jae-Hong Lee","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Samsung Medical Center","Sang Won Seo","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["The Catholic Univ. of Korea Seoul St. Mary's Hospital","Dong Won Yang","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Kyungpook National University Chilgok Hospital","Ho-Won Lee","韩国","Taegu-Kwangyǒkshi","Deagu"],["Medicos Especialistas En Cancer Sc","Sarug Reyes Morales","墨西哥","Aguascalientes","Aguascalientes"],["Investigacion y Biomedicina de Chihuahua","Sandra Silva","墨西哥","Chihuahua","Chihuahua"],["Health Pharma Professional Research S.A. de C.V:","Edilberto Pe？a de Leon","墨西哥","Distrito Federal","Ciudad de México"],["Grupo Medico Camino Sc","Freddy Castro Farfan","墨西哥","Distrito Federal","Mexico City"],["Boca Clinical Trials Mexico S.C.","Hector Cruz Neri","墨西哥","Jalisco","Guadajalara"],["Centro de Investigación Clínica y Medicina Traslacional (CIMeT)","Omar Cardenas-Saenz","墨西哥","Jalisco","Guadalajara"],["Avix Investigación Clinica, S.C.","Amador Macias","墨西哥","Nuevo León","Monterrey"],["Hospital Universitario","Ricardo Salinas- Martinez","墨西哥","Nuevo León","Monterrey"],["Centro de Investigacion Clinica de Oaxaca","Gabriela Arango Salazar","墨西哥","Oaxaca","Oaxaca de Juarez"],["Medical Care and Research SA de CV","Jose Gien Lopez","墨西哥","Yucatán","Merida"],["SCB Research Center","William Julio","墨西哥","Puerto Rico","Bayamon"],["Caribbean Medical Research Center","Angel Maldonado","墨西哥","Puerto Rico","San Juan"],["INSPIRA Clinical Research","Yvette Cruz-Pagan","墨西哥","Puerto Rico","San Juan"],["Instituto De Neurologia Dra. Ivonne Fraga","Ivonne Fraga","墨西哥","Puerto Rico","San Juan"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["复旦大学附属华山医院伦理审查委员会","同意","2024-11-25"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 72 ； 国际: 1200 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；