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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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

Other trials in China

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

Other trials in Argentina

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

Other trials in Australia

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

Other trials in South Korea

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

Other trials in United Kingdom

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

Other trials in Taiwan

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

Other trials in Poland

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

Other trials in Spain

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.

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 groups in NCT05508789
Study groupRoleWhat they receive
DonanemabExperimentalParticipants will receive donanemab intravenously (IV)
Receives: Drug: Donanemab
PlaceboPlacebo comparatorParticipants will receive placebo IV
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 76

Secondary outcomes (8)

  1. Change from Baseline on the iADRS

    Change from baseline on the iADRS in the overall population.

    Measured: Baseline, Week 76

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Pharmacokinetics (PK): Trough Serum Concentration of Donanemab

    Measured: Baseline to Week 76

  8. 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.

  1. First posted19 Aug 2022
  2. Study start10 Oct 2022
  3. Primary completionMay 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in China, Argentina, Australia, South Korea, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (time frame: Baseline, Week 76). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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