Alzheimer DiseasePhase 3NCT05508789
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
A Phase 3 study testing Donanemab in people with Alzheimer Disease and Dementia, run by Eli Lilly and Company at 141 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Brain Diseases
- What is being tested?
- Donanemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 141 sitesin 8 countries
- Study dates
- 10 Oct 2022to Jul 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
141 sites in 8 countries.
141 sites in 8 countries
China50 sites
Beijing Hospital
Beijing, 100005
Beijing ChaoYang Hospital
Beijing, 100020
Beijing Friendship Hospital Affiliate of Capital University
Beijing, 100050
Xuanwu Hospital Capital Medical University
Beijing, 100053
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, 100071
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
Beijing Peking Union Medical College Hospital
Beijing, 100730
Chinese PLA General Hospital
Beijing, 100853
The First Hospital of Jilin University
Changchun, 100012
Xiangya Hospital Central South University
Changsha, 410008
The Second Xiangya Hospital of Central South University
Changsha, 410011
Sichuan Provincial People's Hospital
Chengdu, 610072
West China Hospital, Sichuan University
Chengdu
The First Afffiliated Hospital of Chongqing Medical University
Chongqing, 400016
Fujian Medical University Union Hospital-1 Bingfanglou
Fuzhou Fujian, 350001
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
Guangzhou First People's Hospital
Guangzhou, 510180
Guangdong Provincial People's Hospital
Guangzhou
Peking University Sixth Hospital
Haidian District, 100191
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Sir Run Run Shaw Hospital
Hangzhou, 310016
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, 150001
Jinan Central Hospital
Jinan, 250013
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210000
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
Nanjing Brain Hospital
Nanjing, 210029
Shanghai Mental Health Center
Shanghai, 200030
Shanghai Sixth People's Hospital
Shanghai, 200030
Huashan Hospital Affiliated Fudan University
Shanghai, 200040
Shanghai Tongji Hospital
Shanghai, 200065
Shanghai General Hospital
Shanghai, 200080
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200092
Shanghai East Hospital
Shanghai, 200120
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Tianjin Huanhu Hospital
Tianjin, 300050
Tianjin Medical University General Hospital
Tianjin, 300052
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030
Renmin Hospital of Wuhan University
Wuhan, 430060
Wuxi People's Hospital
Wuxi, 214023
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
Xi'an, 710038
Xianyang Hospital of Yan'an University
Xianyang, 712000
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221006
Xuzhou Central Hospital
Xuzhou, 221018
Affiliated Hospital of Jiangsu University
Zhenjiang, 212000
Argentina16 sites
Hospital Italiano de Buenos Aires
ABB, C1199ABB
Clinica Privada Banfield
Banfield, B1828CKR
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, 1133
Stat Research S.A.
Buenos Aires, C1023AAB
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI
CIPREC
Buenos Aires, C1061AAS
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC
Centro Médico Arsema
Buenos Aires, C1427CCL
Instituto Geriatrico Nuestra Señora de Las Nieves
Buenos Aires, C1427CCP
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, C1428AQK
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, C1012AAR
INSA Instituto de Neurociencia San Agustin
La Plata, 1900
Instituto De Investigaciones Clinicas Quilmes
Quilmes, 1878
INECO Neurociencias Oroño
Rosario, 2000
Australia16 sites
Emeritus Research
Botany, 2019
Box Hill Hospital
Box Hill, 3128
The Prince Charles Hospital
Brisbane, 4032
NeuroCentrix
Carlton, 3053
Central Coast Neurosciences Research
Erina, 2250
Austin Health
Ivanhoe, 3079
Southern Neurology
Kogarah, 2217
HammondCare
Malvern, 3144
The Alfred Hospital
Melbourne, 3004
Alzheimer's Research Australia
Nedlands, 6009
The Royal Melbourne Hospital
Parkville, 3050
St Vincent's Hospital
Sydney, 2010
KARA Institute for Neurological Diseases
Sydney, 2113
Central Coast Neurosciences Research (Tumbi Umbi)
Tumbi Vmbi, 2261
Neurodegenerative Disorders Research
West Perth, 6005
The Queen Elizabeth Hospital
Woodville, 5011
South Korea16 sites
Pusan National University Hospital
Busan, 49241
Hanyang University Guri Hospital
Guri-si, 11923
Chonnam National University Hospital
Gwangju, 61469
Inha University Hospital
Incheon, 22332
Chungnam national university hospital
Junggu, 35015
Gachon University Gil Medical Center
Namdong-gu, 21565
Seoul National University Bundang Hospital
Seongnam, 13620
Seoul National University Bundang Hospital
Seongnam-si, 13605
Korea University Anam Hospital
Seoul, 02841
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
Hanyang University Seoul Hospital
Seoul, 04763
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Ewha Womans University Seoul Hospital
Seoul, 07804
Ajou University Hospital
Suwon, 16499
United Kingdom15 sites
The Rice Centre - Royal United Hospital
Bath, BA1 3NG
Re:Cognition Health - Birmingham
Birmingham, B16 8LT
Re:Cognition Health - Bristol
Bristol, BS32 4SY
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 9AU
Dementia Research Unit
Crowborough, TN6 1NY
Re:Cognition Health - Guildford
Guildford, GU2 7YD
St. George's Hospital
London, SW17 0RE
University College London Hospital
London, W1CN 3BG
Re:Cognition Health - London
London, W1G 8TB
Charing Cross Hospital
London, W6 8RF
Queen's Medical Centre, Nottingham University Hospitals
Nottinghamshire, NG7 2UH
Re:Cognition Health - Plymouth
Plymouth, PL6 8BT
Royal Preston Hospital
Preston, PR2 9HT
Moorgreen Hospital
Southampton, SO30 3JB
Re:Cognition Health - Winchester
Winchester, SO23 8SR
Taiwan11 sites
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
Douliu, 640
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao-Sung Dist, 83301
Cardinal Tien Hospital
New Taipei City, 231
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
New Taipei Municipal TuCheng Hospital
New Taipei City, 236
China Medical University Hospital
Taichung, 404332
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Poland9 sites
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
Centrum Medyczne NEUROMED
Bydgoszcz, 85-163
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Klinika Neuro-Care
Katowice, 40-749
Diamond Clinic
Krakow, 31-559
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, 61-853
Centrum Medyczne Euromedis
Szczecin, 70-111
Centrum Medyczne NeuroProtect
Warsaw, 01-684
Wroclawskie Centrum Alzheimerowskie
Wroclaw, 53-659
Spain8 sites
Barcelonabeta Brain Research Center
Barcelona, 08005
Fundació ACE
Barcelona, 08028
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitari de Santa Maria
Lleida, 25198
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 08915
Hospital Universitario Doctor Peset
Valencia, 46017
Hospital Universitari i Politecnic La Fe
Valencia, 46026
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies
- Being tested
- Donanemab, Placebo
- Keywords
- Alzheimer's, Dementia, Cognitive Impairment, Amyloid Plaque
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
Also called (LY3002813)
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Donanemab | Experimental | Participants will receive donanemab intravenously (IV) Receives: Drug: Donanemab |
| Placebo | Placebo comparator | Participants will receive placebo IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 76
Secondary outcomes (8)
Change from Baseline on the iADRS
Change from baseline on the iADRS in the overall population.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 76
Pharmacokinetics (PK): Trough Serum Concentration of Donanemab
Measured: Baseline to Week 76
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)
Measured: Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start10 Oct 2022
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508789
- Sponsor's protocol ID
- 18442
- Other IDs
- I5T-MC-AACO, 2025-522340-40-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.