A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

April 15, 2024 updated by: Eli Lilly and Company

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1427CCP
        • Not yet recruiting
        • Instituto Geriatrico Nuestra Señora de Las Nieves
        • Principal Investigator:
          • Fernando Taragano
      • Buenos Aires, Argentina, C1428AQK
        • Not yet recruiting
        • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
        • Principal Investigator:
          • Ricardo Allegri
      • Buenos Aires, Argentina, C1431FWO
        • Not yet recruiting
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)
        • Principal Investigator:
          • Patricio Perez Leguizamon
    • Buenos Aires
      • Banfield, Buenos Aires, Argentina, B1828CKR
        • Not yet recruiting
        • Clínica Privada Banfield
        • Principal Investigator:
          • Eduardo Amado Cattaneo
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
        • Not yet recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Principal Investigator:
          • Griselda Russo
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1012AAR
        • Not yet recruiting
        • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas
        • Principal Investigator:
          • Daniel Politis
      • La Plata, Buenos Aires, Argentina, 1900
        • Not yet recruiting
        • INSA Instituto de Neurociencia San Agustin
        • Principal Investigator:
          • Hector Lamaison
      • Quilmes, Buenos Aires, Argentina, 1878
        • Not yet recruiting
        • Instituto de Investigaciones Clinicas Quilmes
        • Principal Investigator:
          • Tomás Sanchez Coleman
    • Ciudad Autónoma De Buenos Aires
      • ABB, Ciudad Autónoma De Buenos Aires, Argentina, C1199ABB
        • Not yet recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Principal Investigator:
          • Daniel Bernardo Seinhart
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1023AAB
        • Not yet recruiting
        • Stat Research S.A.
        • Principal Investigator:
          • Conrado Estol
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
        • Not yet recruiting
        • Mautalen Salud e Investigación
        • Principal Investigator:
          • Bibiana Saravia
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1061AAS
        • Not yet recruiting
        • CIPREC
        • Principal Investigator:
          • Agustina Granada
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1133
        • Not yet recruiting
        • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
        • Principal Investigator:
          • Ricardo Corral
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, C1430EGF
        • Not yet recruiting
        • Clinica Adventista Belgrano
        • Principal Investigator:
          • Diego Castro
      • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1425AGC
        • Not yet recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
        • Principal Investigator:
          • Jose Crespo
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Not yet recruiting
        • INECO Neurociencias Oroño
        • Principal Investigator:
          • Dario Tavolini
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Not yet recruiting
        • Optimus Clinical Research
        • Principal Investigator:
          • Paul Bird
      • Erina, New South Wales, Australia, 2250
        • Not yet recruiting
        • Central Coast Neurosciences Research
        • Principal Investigator:
          • Denis Crimmins
      • Kogarah, New South Wales, Australia, 2217
        • Not yet recruiting
        • Southern Neurology
        • Principal Investigator:
          • Raymond Schwartz
      • Sydney, New South Wales, Australia, 2010
        • Not yet recruiting
        • St Vincent's Hospital
        • Principal Investigator:
          • Bruce Brew
      • Sydney, New South Wales, Australia, 2113
        • Not yet recruiting
        • KARA Institute for Neurological Diseases
        • Principal Investigator:
          • Rosalyn Lai
      • Tumbi Umbi, New South Wales, Australia, 2261
        • Not yet recruiting
        • Central Coast Neurosciences Research (Tumbi Umbi)
        • Principal Investigator:
          • Jonathan Sturm
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Not yet recruiting
        • The Prince Charles Hospital
        • Principal Investigator:
          • Gurudev Kewalram
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Not yet recruiting
        • The Queen Elizabeth Hospital
        • Principal Investigator:
          • Cathy Short
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Not yet recruiting
        • Box Hill Hospital
        • Principal Investigator:
          • Amy Brodtmann
      • Carlton, Victoria, Australia, 3053
        • Not yet recruiting
        • NeuroCentrix
        • Principal Investigator:
          • David Barton
      • Glen Iris, Victoria, Australia, 3146
        • Not yet recruiting
        • Delmont Private Hospital
        • Principal Investigator:
          • Peter Drysdale
      • Ivanhoe, Victoria, Australia, 3079
        • Not yet recruiting
        • Austin Health
        • Principal Investigator:
          • Paul Yates
      • Malvern, Victoria, Australia, 3144
        • Not yet recruiting
        • HammondCare
        • Principal Investigator:
          • Stephen Macfarlane
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • The Alfred Hospital
        • Principal Investigator:
          • David Darby
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Not yet recruiting
        • Australian Alzheimer's Research Foundation Inc.
        • Principal Investigator:
          • Roger Clarnette
      • Perth, Western Australia, Australia, 6005
        • Not yet recruiting
        • Neurodegenerative Disorders Research
        • Principal Investigator:
          • Peter Panegyres
  • China
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • Gang Li
      • Shijiazhuang, China, 050031
        • Recruiting
        • The First Hospital Of Hebei Medical University
        • Contact:
          • Phone Number: 031185917000
        • Principal Investigator:
          • Ping Gu
      • Wuhan, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Shan Ping Mao
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Principal Investigator:
          • jianjun jia
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital
        • Principal Investigator:
          • Yongbo ZHANG
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Peking Union Medical College Hospital
        • Principal Investigator:
          • Jing Gao
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing ChaoYang Hospital
        • Contact:
          • Phone Number: 01085231000
        • Principal Investigator:
          • Wenli HU
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
          • Phone Number: 01083199448
        • Principal Investigator:
          • Jianping Jia
      • Beijing, Beijing, China, 100088
        • Recruiting
        • Beijing Anding Hospital - Affiliated Capital University of Medical Science
        • Contact:
          • Phone Number: 8613811591959
        • Principal Investigator:
          • Qinge Zhang
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Beijing Tiantan Hospital Affiliated to Capital Medical University
        • Contact:
          • Phone Number: 01059978585
        • Principal Investigator:
          • Wei Zhang
      • Haidian District, Beijing, China, 100191
        • Recruiting
        • Peking University Sixth Hospital
        • Principal Investigator:
          • Huali Wang
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Afffiliated Hospital of Chongqing Medical University
        • Contact:
          • Phone Number: 13102372730
        • Principal Investigator:
          • Oumei Cheng
    • Fujian
      • Fuzhou Fujian, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital-1 Bingfanglou
        • Principal Investigator:
          • Qinyong Ye
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Principal Investigator:
          • Yamei Tang
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Principal Investigator:
          • Xiao Ping PAN
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Phone Number: 02083827812
        • Principal Investigator:
          • Lijuan Wang
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Yuhua Fan
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology
        • Contact:
          • Phone Number: 02783663324
        • Principal Investigator:
          • Min Zhang
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Phone Number: 073189753041
        • Principal Investigator:
          • Lu Shen
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Phone Number: 18673111288
        • Principal Investigator:
          • Jie Zhang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
          • Phone Number: 02556662171
        • Principal Investigator:
          • Meijiang Feng
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
        • Principal Investigator:
          • Yun Xu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Nanjing Brain Hospital
        • Contact:
          • Phone Number: 02582296261
        • Principal Investigator:
          • Ligang Xu
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Chunfeng Liu
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
          • Phone Number: 051085351570
        • Principal Investigator:
          • Feng Wang
      • Xuzhou, Jiangsu, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
          • Phone Number: 18052268197
        • Principal Investigator:
          • Deqin Geng
      • Xuzhou, Jiangsu, China, 221018
        • Recruiting
        • XuZhou Central Hospital
        • Contact:
          • Phone Number: 0516111111
        • Principal Investigator:
          • Guofang Chen
      • Zhenjiang, Jiangsu, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Ming Yu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital Of NanChang University
        • Principal Investigator:
          • Zhenyu Tang
    • Jilin
      • Changchun, Jilin, China, 100012
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Phone Number: 13504313689
        • Principal Investigator:
          • Sun Li
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
        • Principal Investigator:
          • Wei Zhang
      • Xianyang, Shaanxi, China, 712000
        • Recruiting
        • XianYang Hospital OF Yan'an University
        • Principal Investigator:
          • Xiaoying Gong
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Hong Bian
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
          • Phone Number: 02134773440
        • Principal Investigator:
          • Xia Li
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
          • Phone Number: 021111111
        • Principal Investigator:
          • Yuncheng Wu
      • Shanghai, Shanghai, China, 200065
        • Recruiting
        • Shanghai Tongji Hospital
        • Principal Investigator:
          • Yunxia Li
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
          • Phone Number: 02124056429
        • Principal Investigator:
          • Qihao Guo
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital Affiliated Fudan University
        • Contact:
          • Phone Number: 021111111
        • Principal Investigator:
          • Jintai Yu
      • Shanghai, Shanghai, China
        • Recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:
          • Phone Number: 02125077501
        • Principal Investigator:
          • Zhenguo Liu
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Phone Number: 18980602127
        • Principal Investigator:
          • Huifang Shang
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Nengwei Yu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Phone Number: 13805736335
        • Principal Investigator:
          • Wei Chen
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Principal Investigator:
          • Guoping PENG
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Phone Number: 13958167260
        • Principal Investigator:
          • Zhang Baorong
  • Korea, Republic of
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital
        • Principal Investigator:
          • Seong Hye Choi
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Kee Hyung Park
    • Kwangju-Kwangyǒkshi
      • Gwangju-si, Kwangju-Kwangyǒkshi, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Principal Investigator:
          • Byeong Chae Kim
    • Kyǒnggi-do
      • Guri-si, Kyǒnggi-do, Korea, Republic of, 11923
        • Recruiting
        • Hanyang University Guri Hospital
        • Principal Investigator:
          • Seong-Ho Koh
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Young Ho Park
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13605
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Ki Woong Kim
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49241
        • Not yet recruiting
        • Pusan National University Hospital
        • Principal Investigator:
          • EUN JOO KIM
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Phone Number: 82230103446
        • Principal Investigator:
          • Jae-Hong Lee
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Sang Won Seo
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Kun Woo Park
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05030
        • Recruiting
        • Konkuk University Medical Center
        • Principal Investigator:
          • Seol-Heui Han
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Principal Investigator:
          • YongSoo Shim
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Seoul Hospital
        • Contact:
          • Phone Number: 82222908374
        • Principal Investigator:
          • Hee-Jin Kim
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 07804
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Principal Investigator:
          • Jee Hyang Jeong
    • Taejǒn-Kwangyǒkshi
      • Jung-gu, Taejǒn-Kwangyǒkshi, Korea, Republic of, 35015
        • Recruiting
        • Chungnam National University Hospital
        • Principal Investigator:
          • Ae Young Lee
    • Yeongtong-gu
      • Gyeonggi-do, Yeongtong-gu, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • So Young Moon
  • Taiwan
      • New Taipei, Taiwan, 235
        • Not yet recruiting
        • Taipei Medical University Shuang Ho Hospital
        • Principal Investigator:
          • Chaur-Jong Hu
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Phone Number: 886422052121
        • Principal Investigator:
          • Yu-Wan Yang
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: 886972401434
        • Principal Investigator:
          • MingChyi Pai
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Ta-Fu Chen
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Contact:
          • Phone Number: 88633281200
        • Principal Investigator:
          • Yi-Chun Chen
    • Kaohsiung
      • Kaohsiung Niao-Sung Dist, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
        • Contact:
          • Phone Number: 88677317123
        • Principal Investigator:
          • Chiung-Chih Chang
    • New Taipei
      • New Taipei City, New Taipei, Taiwan, 231
        • Not yet recruiting
        • Cardinal Tien Hospital
        • Contact:
          • Phone Number: 0222193391
        • Principal Investigator:
          • Yi-Chien Liu
      • New Taipei City, New Taipei, Taiwan, 236
        • Not yet recruiting
        • New Taipei Municipal TuCheng Hospital
        • Principal Investigator:
          • Jung Lung Hsu
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Not yet recruiting
        • Tri-Service General Hospital
        • Contact:
          • Phone Number: 00886987456532
        • Principal Investigator:
          • fu-chi yang
      • Taipei City, Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Phone Number: 886228757578
        • Principal Investigator:
          • Jong-Ling Fuh
    • Yunlin
      • Douliu City, Yunlin, Taiwan, 640
        • Recruiting
        • National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
        • Contact:
          • Phone Number: 0919133429
        • Principal Investigator:
          • Chen-Wen Fang
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Recruiting
        • The Rice Centre - Royal United Hospital
        • Principal Investigator:
          • Tomas Welsh
      • Birmingham, United Kingdom, B16 8LT
        • Recruiting
        • Re:Cognition Health - Birmingham
        • Principal Investigator:
          • Conor Clerkin-Oliver
      • Plymouth, United Kingdom, PL6 8BT
        • Recruiting
        • Re:Cognition Health - Plymouth
        • Principal Investigator:
          • Stephen Mullin
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS32 4SY
        • Recruiting
        • Re:Cognition Health - Bristol
        • Principal Investigator:
          • Daniel Lashley
    • East Sussex
      • Crowborough, East Sussex, United Kingdom, TN6 1NY
        • Not yet recruiting
        • Dementia Research Unit
        • Principal Investigator:
          • Naji Tabet
    • England
      • Chertsey, England, United Kingdom, KT16 9AU
        • Not yet recruiting
        • Surrey and Borders Partnership NHS Foundation Trust
        • Principal Investigator:
          • Ramin Nilforooshan
      • London, England, United Kingdom, SW17 0RE
        • Not yet recruiting
        • St. George's Hospital
        • Principal Investigator:
          • Jeremy Isaacs
    • Hammersmith And Fulham
      • London, Hammersmith And Fulham, United Kingdom, W6 8RF
        • Not yet recruiting
        • Charing Cross Hospital
        • Principal Investigator:
          • Richard Perry
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO30 3JB
        • Not yet recruiting
        • Moorgreen Hospital
        • Principal Investigator:
          • Brady McFarlane
      • Winchester, Hampshire, United Kingdom, SO21 1HU
        • Recruiting
        • Re:Cognition Health - Winchester
        • Principal Investigator:
          • Anna Podonyi
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Not yet recruiting
        • Royal Preston Hospital
        • Principal Investigator:
          • Salman Karim
    • London, City Of
      • London, London, City Of, United Kingdom, W1G 9JF
        • Recruiting
        • Re:Cognition Health - London
        • Principal Investigator:
          • Josephine MacSweeney
    • Nottingham
      • Nottinghamshire, Nottingham, United Kingdom, NG7 2UH
        • Not yet recruiting
        • Queen's Medical Centre, Nottingham University Hospitals
        • Principal Investigator:
          • Akram A. Hosseini
    • Reading
      • Guildford, Reading, United Kingdom, GU2 7YD
        • Recruiting
        • Re:Cognition Health Guildford
        • Principal Investigator:
          • Nicholas Mannering

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by the participant or informant for ≥6 months
  • A MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
  • Meet flortaucipir F18 scan (central read) criteria
  • Meet florbetapir F18 scan (central read) criteria
  • Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
  • A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
  • If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.

  • Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

    • AEs and concomitant medications
    • CDR, and
    • ADCS-ADL
  • Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria:

  • Has significant neurological disease affect the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
  • History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
  • Contraindication to MRI or PET scans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donanemab
Participants will receive donanemab intravenously (IV)
Drug: Donanemab
Administered IV
Other Names:
  • (LY3002813)
Placebo Comparator: Placebo
Participants will receive placebo IV
Drug: Placebo
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Time Frame: Baseline, Week 76
Change from Baseline on the iADRS in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time Frame: Baseline, Week 76
Change from Baseline CDR-SB in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale ADAS-Cog13 Score
Time Frame: Baseline, Week 76
Change from Baseline on the ADAS-Cog13 Score in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living ADCS-iADL Score
Time Frame: Baseline, Week 76
Change from Baseline ADCS-iADL Score in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76
Change from Baseline on the Mini Mental State Examination (MMSE) Score
Time Frame: Baseline, Week 76
Change from Baseline on the MMSE Score in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76
Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan
Time Frame: Baseline, Week 76
Baseline, Week 76
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Time Frame: Baseline to Week 76
Baseline to Week 76
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)
Time Frame: Week 76
Week 76
Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD)
Time Frame: Baseline, Week 76
Change from baseline in the QoL-AD in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76
Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite)
Time Frame: Baseline, Week 76
Change from baseline in the RUD-Lite in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76
Change from Baseline in Neuropsychiatric Inventory (NPI)
Time Frame: Baseline, Week 76
Change from baseline in the NPI in at least one of 'the low-medium tau pathology population or the overall population'.
Baseline, Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

April 16, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18442 (City of Hope Medical Center)
  • I5T-MC-AACO (Other Identifier: Eli Lilly and Company)
  • 2021-006395-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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