A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
3 other identifiers
interventional
1,500
8 countries
141
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Oct 2022
Longer than P75 for phase_3 alzheimer-disease
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
June 3, 2026
June 1, 2026
5.6 years
August 18, 2022
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Change from Baseline on the iADRS in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology population.
Baseline, Week 76
Secondary Outcomes (8)
Change from Baseline on the iADRS
Baseline, Week 76
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score
Baseline, Week 76
Change from Baseline on the Mini Mental State Examination (MMSE) Score
Baseline, Week 76
- +3 more secondary outcomes
Study Arms (2)
Donanemab
EXPERIMENTALParticipants will receive donanemab intravenously (IV)
Placebo
PLACEBO COMPARATORParticipants will receive placebo IV
Interventions
Eligibility Criteria
You may qualify if:
- 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 screening visit.
- Meet amyloid 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.
You may not qualify if:
- Has significant neurological disease affecting 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (141)
Hospital Italiano de Buenos Aires
ABB, C1199ABB, Argentina
Clinica Privada Banfield
Banfield, B1828CKR, Argentina
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, 1133, Argentina
Stat Research S.A.
Buenos Aires, C1023AAB, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Centro Médico Arsema
Buenos Aires, C1427CCL, Argentina
Instituto Geriatrico Nuestra Señora de Las Nieves
Buenos Aires, C1427CCP, Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, C1428AQK, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO, Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, C1012AAR, Argentina
INSA Instituto de Neurociencia San Agustin
La Plata, 1900, Argentina
Instituto De Investigaciones Clinicas Quilmes
Quilmes, 1878, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Emeritus Research
Botany, 2019, Australia
Box Hill Hospital
Box Hill, 3128, Australia
The Prince Charles Hospital
Brisbane, 4032, Australia
NeuroCentrix
Carlton, 3053, Australia
Central Coast Neurosciences Research
Erina, 2250, Australia
Austin Health
Ivanhoe, 3079, Australia
Southern Neurology
Kogarah, 2217, Australia
HammondCare
Malvern, 3144, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Alzheimer's Research Australia
Nedlands, 6009, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
St Vincent's Hospital
Sydney, 2010, Australia
KARA Institute for Neurological Diseases
Sydney, 2113, Australia
Central Coast Neurosciences Research (Tumbi Umbi)
Tumbi Vmbi, 2261, Australia
Neurodegenerative Disorders Research
West Perth, 6005, Australia
The Queen Elizabeth Hospital
Woodville, 5011, Australia
Beijing Hospital
Beijing, 100005, China
Beijing ChaoYang Hospital
Beijing, 100020, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, 100050, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, 100071, China
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088, China
Beijing Peking Union Medical College Hospital
Beijing, 100730, China
Chinese PLA General Hospital
Beijing, 100853, China
The First Hospital of Jilin University
Changchun, 100012, China
Xiangya Hospital Central South University
Changsha, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
West China Hospital, Sichuan University
Chengdu, China
The First Afffiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Fujian Medical University Union Hospital-1 Bingfanglou
Fuzhou Fujian, 350001, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120, China
Guangzhou First People's Hospital
Guangzhou, 510180, China
Guangdong Provincial People's Hospital
Guangzhou, China
Peking University Sixth Hospital
Haidian District, 100191, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
Sir Run Run Shaw Hospital
Hangzhou, 310016, China
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, 150001, China
Jinan Central Hospital
Jinan, 250013, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210000, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011, China
Nanjing Brain Hospital
Nanjing, 210029, China
Shanghai Mental Health Center
Shanghai, 200030, China
Shanghai Sixth People's Hospital
Shanghai, 200030, China
Huashan Hospital Affiliated Fudan University
Shanghai, 200040, China
Shanghai Tongji Hospital
Shanghai, 200065, China
Shanghai General Hospital
Shanghai, 200080, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200092, China
Shanghai East Hospital
Shanghai, 200120, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Huanhu Hospital
Tianjin, 300050, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Wuxi People's Hospital
Wuxi, 214023, China
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
Xi'an, 710038, China
Xianyang Hospital of Yan'an University
Xianyang, 712000, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221006, China
Xuzhou Central Hospital
Xuzhou, 221018, China
Affiliated Hospital of Jiangsu University
Zhenjiang, 212000, China
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, 85-163, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Klinika Neuro-Care
Katowice, 40-749, Poland
Diamond Clinic
Krakow, 31-559, Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, 61-853, Poland
Centrum Medyczne Euromedis
Szczecin, 70-111, Poland
Centrum Medyczne NeuroProtect
Warsaw, 01-684, Poland
Wroclawskie Centrum Alzheimerowskie
Wroclaw, 53-659, Poland
Pusan National University Hospital
Busan, 49241, South Korea
Hanyang University Guri Hospital
Guri-si, 11923, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chungnam national university hospital
Junggu, 35015, South Korea
Gachon University Gil Medical Center
Namdong-gu, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Barcelonabeta Brain Research Center
Barcelona, 08005, Spain
Fundació ACE
Barcelona, 08028, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitari de Santa Maria
Lleida, 25198, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 08915, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
Douliu, 640, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao-Sung Dist, 83301, Taiwan
Cardinal Tien Hospital
New Taipei City, 231, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, 236, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
The Rice Centre - Royal United Hospital
Bath, BA1 3NG, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, B16 8LT, United Kingdom
Re:Cognition Health - Bristol
Bristol, BS32 4SY, United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 9AU, United Kingdom
Dementia Research Unit
Crowborough, TN6 1NY, United Kingdom
Re:Cognition Health - Guildford
Guildford, GU2 7YD, United Kingdom
St. George's Hospital
London, SW17 0RE, United Kingdom
University College London Hospital
London, W1CN 3BG, United Kingdom
Re:Cognition Health - London
London, W1G 8TB, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottinghamshire, NG7 2UH, United Kingdom
Re:Cognition Health - Plymouth
Plymouth, PL6 8BT, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Re:Cognition Health - Winchester
Winchester, SO23 8SR, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2022
First Posted
August 19, 2022
Study Start
October 10, 2022
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.