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

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: Active, not recruiting
• Conditions: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Alzheimer Disease; Tauopathies
• Intervention / Treatment: Drug: Placebo; Drug: Donanemab

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) and the presence of AD pathology.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • ABB, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Banfield, Argentina, B1828CKR
    • Clinica Privada Banfield
  • Buenos Aires, Argentina, C1023AAB
    • STAT Research S.A.
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Buenos Aires, Argentina, C1056ABI
    • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires, Argentina, C1425AGC
    • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Buenos Aires, Argentina, C1128AAF
    • Mautalen Salud e Investigación
  • Buenos Aires, Argentina, C1427CCL
    • Centro Médico Arsema
  • Buenos Aires, Argentina, C1428AQK
    • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
  • Buenos Aires, Argentina, 1133
    • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
  • Buenos Aires, Argentina, C1431FWO
    • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
  • Buenos Aires, Argentina, C1427CCP
    • Instituto Geriatrico Nuestra Señora de Las Nieves
  • Ciudad de Buenos Aires, Argentina, C1012AAR
    • IDIM - Instituto de Investigaciones Metabólicas
  • La Plata, Argentina, 1900
    • INSA Instituto de Neurociencia San Agustin
  • Quilmes, Argentina, 1878
    • Instituto de Investigaciones Clinicas Quilmes
  • Rosario, Argentina, 2000
    • INECO Neurociencias Oroño
• Australia
  • Botany, Australia, 2019
    • Emeritus Research
  • Box Hill, Australia, 3128
    • Box Hill Hospital
  • Brisbane, Australia, 4032
    • The Prince Charles Hospital
  • Carlton, Australia, 3053
    • NeuroCentrix
  • Erina, Australia, 2250
    • Central Coast Neurosciences Research
  • Ivanhoe, Australia, 3079
    • Austin Health
  • Kogarah, Australia, 2217
    • Southern Neurology
  • Malvern, Australia, 3144
    • HammondCare
  • Melbourne, Australia, 3004
    • The Alfred Hospital
  • Nedlands, Australia, 6009
    • Alzheimer's Research Australia
  • Parkville, Australia, 3050
    • The Royal Melbourne Hospital
  • Sydney, Australia, 2010
    • St Vincent's Hospital
  • Sydney, Australia, 2113
    • KARA Institute for Neurological Diseases
  • Tumbi Vmbi, Australia, 2261
    • Central Coast Neurosciences Research (Tumbi Umbi)
  • West Perth, Australia, 6005
    • Neurodegenerative Disorders Research
  • Woodville, Australia, 5011
    • The Queen Elizabeth Hospital
• China
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing, China, 100053
    • Xuanwu Hospital Capital Medical University
  • Beijing, China, 100730
    • Beijing Peking Union Medical College Hospital
  • Beijing, China, 100005
    • Beijing Hospital
  • Beijing, China, 100020
    • Beijing Chaoyang Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital Affiliate of Capital University
  • Beijing, China, 100071
    • Beijing Tiantan Hospital Affiliated to Capital Medical University
  • Beijing, China, 100088
    • Beijing Anding Hospital - Affiliated Capital University of Medical Science
  • Changchun, China, 100012
    • The First Hospital of Jilin University
  • Changsha, China, 410008
    • Xiangya Hospital Central South University
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University
  • Chengdu, China
    • West China Hospital, Sichuan University
  • Chengdu, China, 610072
    • Sichuan Provincial People's Hospital
  • Chongqing, China, 400016
    • The First Afffiliated Hospital of Chongqing Medical University
  • Fuzhou Fujian, China, 350001
    • Fujian Medical University Union Hospital-1 Bingfanglou
  • Guangzhou, China
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510080
    • The First Affiliated Hospital, Sun Yat-sen University
  • Guangzhou, China, 510180
    • Guangzhou First People's Hospital
  • Guangzhou, China, 510120
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Haidian District, China, 100191
    • Peking University Sixth Hospital
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, Zhejiang University
  • Hangzhou, China, 310052
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Harbin, China, 150001
    • The Fourth Affiliated Hospital of Harbin Medical University
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Nanchang, China, 330006
    • The Second Affiliated Hospital of Nanchang University
  • Nanjing, China, 210029
    • Nanjing Brain Hospital
  • Nanjing, China, 210011
    • The Second Affiliated Hospital of Nanjing Medical University
  • Nanjing, China, 210000
    • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Shanghai, China, 200080
    • Shanghai General Hospital
  • Shanghai, China, 200065
    • Shanghai Tongji Hospital
  • Shanghai, China, 200030
    • Shanghai Mental Health Center
  • Shanghai, China, 200040
    • Huashan Hospital Affiliated Fudan University
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200120
    • Shanghai East Hospital
  • Shanghai, China, 200030
    • Shanghai sixth people's hospital
  • Shijiazhuang, China, 050031
    • The First Hospital of Hebei Medical University
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University
  • Suzhou, China, 215004
    • The Second Affiliated Hospital of Soochow University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300050
    • Tianjin Huanhu Hospital
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical,Science & Technology
  • Wuxi, China, 214023
    • Wuxi People's Hospital
  • Xi'an, China, 710038
    • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
  • Xianyang, China, 712000
    • Xianyang Hospital of Yan'an University
  • Xuzhou, China, 221006
    • The Affiliated Hospital of Xuzhou Medical College
  • Xuzhou, China, 221018
    • Xuzhou Central Hospital
  • Zhenjiang, China, 212000
    • Affiliated Hospital of Jiangsu University
• Poland
  • Bialystok, Poland, 15-756
    • Podlaskie Centrum Psychogeriatrii
  • Bydgoszcz, Poland, 85-163
    • Centrum Medyczne NEUROMED
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Katowice, Poland, 40-749
    • Klinika Neuro-Care
  • Krakow, Poland, 31-559
    • Diamond Clinic
  • Poznan, Poland, 61-853
    • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
  • Szczecin, Poland, 70-111
    • Centrum Medyczne Euromedis
  • Warsaw, Poland, 01-684
    • Centrum Medyczne NeuroProtect
  • Wroclaw, Poland, 53-659
    • Wroclawskie Centrum Alzheimerowskie
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Guri-si, South Korea, 11923
    • Hanyang University Guri Hospital
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Incheon, South Korea, 22332
    • Inha University Hospital
  • Junggu, South Korea, 35015
    • Chungnam National University Hospital
  • Namdong-gu, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seongnam-si, South Korea, 13605
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital
  • Seoul, South Korea, 07804
    • Ewha Womans University Seoul Hospital
  • Seoul, South Korea, 03312
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Suwon, South Korea, 16499
    • Ajou University Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08005
    • Barcelonabeta Brain Research Center
  • Barcelona, Spain, 08028
    • Fundació ACE
  • Lleida, Spain, 25198
    • Hospital Universitari de Santa Maria
  • Sant Cugat del Vallès, Spain, 08915
    • Hospital Universitari General de Catalunya
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset
• Taiwan
  • Douliu, Taiwan, 640
    • National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
  • Kaohsiung Niao-Sung Dist, Taiwan, 83301
    • Chang Gung Memorial Hospital at Kaohsiung
  • New Taipei City, Taiwan, 231
    • Cardinal Tien Hospital
  • New Taipei City, Taiwan, 235
    • Taipei Medical University Shuang Ho Hospital
  • New Taipei City, Taiwan, 236
    • New Taipei Municipal TuCheng Hospital
  • Taichung, Taiwan, 404332
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • The Rice Centre - Royal United Hospital
  • Birmingham, United Kingdom, B16 8LT
    • Re:Cognition Health - Birmingham
  • Bristol, United Kingdom, BS32 4SY
    • Re:Cognition Health - Bristol
  • Chertsey, United Kingdom, KT16 9AU
    • Surrey and Borders Partnership NHS Foundation Trust
  • Crowborough, United Kingdom, TN6 1NY
    • Dementia Research Unit
  • Guildford, United Kingdom, GU2 7YD
    • Re:Cognition Health - Guildford
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SW17 0RE
    • St. George's Hospital
  • London, United Kingdom, W1CN 3BG
    • University College London Hospital
  • London, United Kingdom, W1G 8TB
    • Re:Cognition Health - London
  • Nottinghamshire, United Kingdom, NG7 2UH
    • Queen's Medical Centre, Nottingham University Hospitals
  • Plymouth, United Kingdom, PL6 8BT
    • Re:Cognition Health - Plymouth
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Southampton, United Kingdom, SO30 3JB
    • Moorgreen Hospital
  • Winchester, United Kingdom, SO23 8SR
    • Re:Cognition Health - Winchester

Participation Criteria

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 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)		Week 76
Change from Baseline on the iADRS	Change from baseline on the iADRS in the overall population.	Baseline, Week 76
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)	Change from Baseline CDR-SB in at least one of the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.	Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score	Change from Baseline on the ADAS-Cog13 Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.	Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score	Change from Baseline ADCS-iADL Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.	Baseline, Week 76
Change from Baseline on the Mini Mental State Examination (MMSE) Score	Change from Baseline on the MMSE Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.	Baseline, Week 76
Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan	Change in brain amyloid plaque deposition in the overall population.	Baseline, Week 76
Pharmacokinetics (PK): Trough Serum Concentration of Donanemab		Baseline to Week 76

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028

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): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Dementia; Amyloid Plaque; Alzheimer's
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Alzheimer Disease; Mental Disorders; Dementia; Brain Diseases; Nervous System Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Plaque, Amyloid; Tauopathies; Substandard Drugs; Pharmaceutical Preparations; donanemab
• Other Study ID Numbers: 18442 (City of Hope Medical Center); I5T-MC-AACO (Other Identifier: Eli Lilly and Company); 2025-522340-40-00 (Ctis)

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