A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
Launched by ELI LILLY AND COMPANY · Aug 18, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The TRAILBLAZER-ALZ 5 trial is studying a medication called donanemab to see if it can help people with early symptoms of Alzheimer’s disease. The goal is to find out how safe the medication is and how well it works over a study period of up to 93 weeks. This trial is currently looking for participants who have noticed gradual changes in their memory for at least six months and have a specific level of cognitive function. Participants will need to have a study partner—someone who is close to them and can help throughout the study.
To be eligible, participants should be between 21 and 85 years old and must be able to undergo certain brain scans. They should also be stable on any current Alzheimer’s medications for about a month before starting the trial. Throughout the study, participants can expect regular check-ins and assessments of their memory and daily functioning. It's important for participants to have someone who can be there to help and provide information during these assessments. Overall, this trial aims to provide valuable insights into a potential new treatment for early Alzheimer’s disease.
Gender
ALL
Eligibility criteria
- 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.
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Box Hill, Victoria, Australia
Parkville, Victoria, Australia
Melbourne, Victoria, Australia
Woodville, South Australia, Australia
Madrid, , Spain
Barcelona, , Spain
Shijiazhuang, Hebei, China
Preston, Lancashire, United Kingdom
Taipei, , Taiwan
Sydney, New South Wales, Australia
Tainan, , Taiwan
Leuven, , Belgium
Guangzhou, Guangdong, China
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Nanjing, Jiangsu, China
Seoul, , Korea, Republic Of
Kogarah, New South Wales, Australia
Brisbane, Queensland, Australia
Beijing, Beijing, China
Seoul, , Korea, Republic Of
Barcelona, , Spain
Changsha, Hunan, China
Shanghai, , China
Changchun, Jilin, China
Taoyuan, , Taiwan
Beijing, Beijing, China
Beijing, Beijing, China
Shanghai, Shanghai, China
Harbin, Heilongjiang, China
Tianjin, Tianjin, China
Guangzhou, Guangdong, China
Wuxi, Jiangsu, China
Nanchang, Jiangxi, China
Shanghai, Shanghai, China
Taipei, , Taiwan
Beijing, Beijing, China
Changsha, Hunan, China
Leuven, Vlaams Brabant, Belgium
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Guangzhou, Guangdong, China
Taipei City, Taipei, Taiwan
Hangzhou, Zhejiang, China
Chengdu, Sichuan, China
Suzhou, Jiangsu, China
Suzhou, Jiangsu, China
Gdansk, Pomorskie, Poland
Wuhan, Hubei, China
Seongnam Si, , Korea, Republic Of
Hangzhou, Zhejiang, China
Valencia, , Spain
Shanghai, Shanghai, China
Beijing, Beijing, China
Guangzhou, Guangdong, China
Beijing, Beijing, China
Shijiazhuang, , China
Barcelona, , Spain
Lleida, , Spain
Busan, , Korea, Republic Of
Beijing, Beijing, China
Hangzhou, Zhejiang, China
Erina, New South Wales, Australia
Shanghai, Shanghai, China
Seoul, , Korea, Republic Of
Hangzhou, Zhejiang, China
Guangzhou, Guangdong, China
Barcelona, , Spain
Xuzhou, Jiangsu, China
Shanghai, Shanghai, China
Quilmes, Buenos Aires, Argentina
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Nanjing, Jiangsu, China
Gent, Oost Vlaanderen, Belgium
Nanjing, Jiangsu, China
Seongnam, Gyeonggi Do, Korea, Republic Of
Schwerin, Mecklenburg Vorpommern, Germany
Tainan, , Taiwan
Hangzhou, Zhejiang, China
West Perth, Western Australia, Australia
Glen Iris, Victoria, Australia
Hasselt, Limburg, Belgium
Shanghai, Shanghai, China
Jinan, Shandong, China
Zhenjiang, Jiangsu, China
Pozuelo De Alarcon, Madrid, Spain
Guri Si, , Korea, Republic Of
Shanghai, Shanghai, China
Mannheim, Baden Württemberg, Germany
Ivanhoe, Victoria, Australia
Gwangju Si, , Korea, Republic Of
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, , Korea, Republic Of
Krakow, , Poland
València, , Spain
Cheng Du, Sichuan, China
Shanghai, Shanghai, China
Beijing, Beijing, China
Kortrijk, West Vlaanderen, Belgium
Botany, New South Wales, Australia
Poznań, Wielkopolskie, Poland
London, Hammersmith And Fulham, United Kingdom
Incheon, , Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Sant Cugat Del Vallès, Barcelona [Barcelona], Spain
Taipei City, Taipei, Taiwan
Beijing, Beijing, China
Hamburg, , Germany
Botany, New South Wales, Australia
Hangzhou, Zhejiang, China
Krakow, Małopolskie, Poland
Chongqing, Chongqing, China
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Taipei City, Taipei, Taiwan
Xuzhou, Jiangsu, China
Warszawa, Mazowieckie, Poland
Malvern, Victoria, Australia
Kladno, , Czechia
Amsterdam, Noord Holland, Netherlands
Zwolle, Overijssel, Netherlands
Wroclaw, Dolnośląskie, Poland
Bydgoszcz, Kujawsko Pomorskie, Poland
Białystok, Podlaskie, Poland
Szczecin, Zachodniopomorskie, Poland
Siemianowice Slaskie, śląskie, Poland
London, London, City Of, United Kingdom
Birmingham, , United Kingdom
Banfield, Buenos Aires, Argentina
Taichung, , Taiwan
Poznan, Wielkopolskie, Poland
Brussels, Bruxelles Capitale, Région De, Belgium
Xi'an, Shaanxi, China
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Rouen, Haute Normandie, France
Seoul, Seoul Teuk, Korea, Republic Of
Shanghai, Shanghai, China
Suwon Si, , Korea, Republic Of
Brussels, Bruxelles Capitale, Région De, Belgium
Kiel, Schleswig Holstein, Germany
Namdong Gu, , Korea, Republic Of
Suwon Si, Kyǒnggi Do, Korea, Republic Of
Barcelona, Barcelona [Barcelona], Spain
Barcelona, Catalunya [Cataluña], Spain
Harbin, Heilongjiang, China
Seoul, , Korea, Republic Of
Sydney, New South Wales, Australia
Tumbi Umbi, New South Wales, Australia
Poznan, Wielkopolskie, Poland
Barcelona, Catalunya [Cataluña], Spain
Valencia, Valenciana, Comunitat, Spain
Guri Si, Kyǒnggi Do, Korea, Republic Of
Piotrkow Trybunalski, łódzkie, Poland
Wuhan, Hubei, China
Munich, Bayern, Germany
Brussels, Bruxelles , Belgium
Liege, Liège, Belgium
Brugge, West Vlaanderen, Belgium
Beijing, Beijing, China
Beijing, Beijing, China
Haidian District, Beijing, China
Fuzhou Fujian, Fujian, China
Changchun, Jilin, China
Xianyang, Shaanxi, China
Tianjin, Tianjin, China
Plzen, Plzeň Měst, Czechia
Praha, Praha 6, Czechia
Hostivice, Středočeský Kraj, Czechia
Kutná Hora, Středočeský Kraj, Czechia
Prague, , Czechia
Rychnov Nad Kněžnou, , Czechia
Colmar, Alsace, France
Strasbourg, Alsace, France
Marseille, Bouches Du Rhône, France
Dijon, Bourgogne, France
Tours, Centre, France
Toulouse, Haute Garonne, France
Montpellier, Languedoc Roussillon, France
Saint Herblain, Loire Atlantique, France
Nancy, Meurthe Et Moselle, France
Toulouse, Midi Pyrénées, France
Lille, Nord Pas De Calais, France
Bron, Rhône, France
Villeurbanne, Rhône, France
Paris, , France
Paris, , France
Rennes, , France
Göttingen, Niedersachsen, Germany
Hannover, Niedersachsen, Germany
Altenburg, Thüringen, Germany
Berlin, , Germany
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
'S Hertogenbosch, Noord Brabant, Netherlands
Klodzko, Dolnośląskie, Poland
Scinawa, Dolnośląskie, Poland
Bydgoszcz, Kujawsko P, Poland
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Białystok, Podlaskie, Poland
Zabrze, śląskie, Poland
Zabrze, śląskie, Poland
Seville, Andalucía, Spain
Barcelona, Barcelona [Barcelona], Spain
Lleida, Lleida [Lérida], Spain
San Sebastián, País Vasco, Spain
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
New Taipei City, New Taipei, Taiwan
Douliu City, Yunlin, Taiwan
New Taipei, , Taiwan
Taipei, , Taiwan
Rosario, Santa Fe, Argentina
Marseille, Bouches Du Rhône, France
Caba, Ciudad Autónoma De Buenos Aires, Argentina
Bristol, , United Kingdom
Piotrkow Trybunalski, łódzkie, Poland
European Union, Rychnov Nad Kněžnou, Czechia
Buenos Aires, , Argentina
Poznań, Wielkopolskie, Poland
Shanghai, Shanghai, China
Bristol, Bristol, City Of, United Kingdom
Winchester, Hampshire, United Kingdom
Guildford, Reading, United Kingdom
Plymouth, , United Kingdom
Marseille, , France
Cheng Du, Sichuan, China
Southampton, Hampshire, United Kingdom
Ciudad De Buenos Aires, Buenos Aires, Argentina
Namdong Gu, , Korea, Republic Of
Piotrkow Trybunalski, łódzkie, Poland
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
New Taipei City, New Taipei, Taiwan
Carlton, Victoria, Australia
Hostivice, Středočeský Kraj, Czechia
Lublin, Lubelskie, Poland
Praha 6, , Czechia
Tours, Centre, France
Bron, Rhône, France
Dijon, , France
Gyeonggi Do, Yeongtong Gu, Korea, Republic Of
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Ciudad De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Chongqing, Chongqing, China
Tours, Centre, France
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Gwangju Si, Kwangju Kwangyǒkshi, Korea, Republic Of
Jung Gu, Taejǒn Kwangyǒkshi, Korea, Republic Of
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Nedlands, Western Australia, Australia
Perth, Western Australia, Australia
Crowborough, East Sussex, United Kingdom
Chertsey, England, United Kingdom
London, England, United Kingdom
Nottinghamshire, Nottingham, United Kingdom
Bath, , United Kingdom
Katowice, śląskie, Poland
Plzen, Plzeň Město, Czechia
La Plata, Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, , Argentina
London, England, United Kingdom
Liege, , Belgium
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Hostivice, , Czechia
Colmar, , France
Seongnam Si, Kyǒnggi Do, Korea, Republic Of
London, London, City Of, United Kingdom
Guildford, Reading, United Kingdom
Barcelona, Barcelona [Barcelona], Spain
Cheng Du, Sichuan, China
Sant Cugat Del Vallès, , Spain
Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Wroclaw, , Poland
Katowice, , Poland
Abb, , Argentina
Buenos Aires, , Argentina
Jung Gu, , Korea, Republic Of
London, , United Kingdom
Patients applied
Trial Officials
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)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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