A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
Launched by ELI LILLY AND COMPANY · Oct 21, 2024
Trial Information
Current as of April 29, 2025
Recruiting
Keywords
ClinConnect Summary
The TRAILRUNNER-ALZ 3 study is looking at a new drug called Remternetug (LY3372993) to see if it can help people with early Alzheimer's disease. The main goal of the trial is to find out if this drug can slow down or prevent problems with memory, thinking, and daily activities compared to a placebo, which is a dummy treatment that doesn’t have the active drug. If you decide to participate, the study could last up to 255 weeks, including time for screenings and treatment periods. Even if you receive the placebo during the initial phase, you may have the option to receive the actual drug later on.
To join the study, participants need to be between 18 and 89 years old and have certain test results indicating early Alzheimer's disease. It's important that they have a reliable partner who knows them well and can help with the study process. Participants should not have other serious health issues that could affect their participation or results. Throughout the study, participants will undergo various assessments to monitor their cognitive abilities and overall health. This trial is currently recruiting, and everyone, regardless of gender, is welcome to apply.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
- • Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- • Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
- • Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
- • Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
- • If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
- Exclusion Criteria:
- • Have dementia or significant other neurological disease that can affect cognition.
- • Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
- • Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
- • Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
- • Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study.
- • Have any contraindications for magnetic resonance imaging (MRI).
- • Have a centrally read MRI that does not meets study entry criteria.
- • Prior or Current Therapies
- • Have ever had prior treatment with a passive anti-amyloid immunotherapy.
- • Have received active immunization against Aβ in any other study.
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
Elk Grove Village, Illinois, United States
Box Hill, Victoria, Australia
Omaha, Nebraska, United States
Parkville, Victoria, Australia
Providence, Rhode Island, United States
Delray Beach, Florida, United States
Woodville, South Australia, Australia
Phoenix, Arizona, United States
West Palm Beach, Florida, United States
Tampa, Florida, United States
Waterloo, Iowa, United States
Shijiazhuang, Hebei, China
Austin, Texas, United States
Taipei, , Taiwan
New Port Richey, Florida, United States
Sydney, New South Wales, Australia
Taichung, , Taiwan
Tainan, , Taiwan
Fort Myers, Florida, United States
Kobe, Hyogo, Japan
Porto Alegre, Rio Grande Do Sul, Brazil
Birmingham, Alabama, United States
Bradenton, Florida, United States
Fresno, California, United States
Woodstock, Georgia, United States
Summerville, South Carolina, United States
Boise, Idaho, United States
Bunkyo Ku, Tokyo, Japan
Nanjing, Jiangsu, China
Kodaira, Tokyo, Japan
Kogarah, New South Wales, Australia
Renton, Washington, United States
East Providence, Rhode Island, United States
Guangzhou, Guangdong, China
Changsha, Hunan, China
Toronto, Ontario, Canada
Atlantis, Florida, United States
Taoyuan, , Taiwan
Blackpool, Lancashire, United Kingdom
Tianjin, Tianjin, China
Bellevue, Washington, United States
Port Orange, Florida, United States
Nanchang, Jiangxi, China
Taipei, , Taiwan
Cordova, Tennessee, United States
San Juan, , Puerto Rico
Topeka, Kansas, United States
Chengdu, Sichuan, China
Farmington Hills, Michigan, United States
Newton, Massachusetts, United States
Córdoba, , Argentina
Peterborough, Ontario, Canada
Suzhou, Jiangsu, China
Boston, Massachusetts, United States
Middleburg Heights, Ohio, United States
Nanchang, Jiangxi, China
Orlando, Florida, United States
Minato Ku, Tokyo, Japan
Toronto, Ontario, Canada
Luoyang, Henan, China
Shanghai, Shanghai, China
Camberwell, Victoria, Australia
Boulder, Colorado, United States
San Diego, California, United States
Indianapolis, Indiana, United States
Guangzhou, Guangdong, China
Xuzhou, Jiangsu, China
Chihuahua, , Mexico
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Nanchang, Jiangxi, China
Toronto, Ontario, Canada
Philadelphia, Pennsylvania, United States
Sacramento, California, United States
Santa Ana, California, United States
Rosario, Santa Fe, Argentina
Wellington, Florida, United States
Chuo Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Saint Paul, Minnesota, United States
Toms River, New Jersey, United States
San Juan, , Puerto Rico
Miami, Florida, United States
Epping, Essex, United Kingdom
Tokyo, , Japan
Jinan, Shandong, China
Ocala, Florida, United States
Porto Alegre, Rio Grande Do Sul, Brazil
San Francisco, California, United States
Guangzhou, Guangdong, China
Gainesville, Georgia, United States
Pozuelo De Alarcon, Madrid, Spain
Springfield, New Jersey, United States
San Diego, California, United States
Dayton, Ohio, United States
Chesterfield, Missouri, United States
Ivanhoe, Victoria, Australia
Marrero, Louisiana, United States
Monroe, North Carolina, United States
New Haven, Connecticut, United States
Winter Park, Florida, United States
Chuo Ku, Tokyo, Japan
Kelowna, British Columbia, Canada
Bangor, Maine, United States
Oxford, Oxfordshire, United Kingdom
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Houston, Texas, United States
Zigong, Sichuan, China
Ipswich, Queensland, Australia
Sarnia, Ontario, Canada
Beaumont, Texas, United States
Waltham, Massachusetts, United States
Kyoto, , Japan
Watertown, Massachusetts, United States
Dallas, Texas, United States
Fairfax, Virginia, United States
Ottawa, Ontario, Canada
Sherbrooke, Quebec, Canada
San M. De Tucuman, Tucumán, Argentina
Cheng Du, Sichuan, China
Hachioji, Tokyo, Japan
Botany, New South Wales, Australia
Hefei, Anhui, China
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Irvine, California, United States
Stamford, Connecticut, United States
Mendoza, , Argentina
São Paulo, , Brazil
Incheon, Incheon Gwangyeoksi [Incheon], Korea, Republic Of
Suita Shi, Osaka, Japan
Stuart, Florida, United States
Maitland, Florida, United States
Greensboro, North Carolina, United States
Ciudad De México, Distrito Federal, Mexico
Basalt, Colorado, United States
Nanjing, Jiangsu, China
Shavano Park, Texas, United States
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Quebec, , Canada
Blacktown, New South Wales, Australia
Kanwal, New South Wales, Australia
Boston, Massachusetts, United States
Xuzhou, Jiangsu, China
Changhua County, Changhua, Taiwan
Mexico City, Distrito Federal, Mexico
Merritt Island, Florida, United States
Greenville, South Carolina, United States
São Paulo, , Brazil
Merida, Yucatán, Mexico
Houston, Texas, United States
Hialeah, Florida, United States
Chicago, Illinois, United States
Aventura, Florida, United States
Plymouth Meeting, Pennsylvania, United States
Malvern, Victoria, Australia
Bayamon, , Puerto Rico
Birmingham, , United Kingdom
Taichung, , Taiwan
Buenos Aires, , Argentina
Xi'an, Shaanxi, China
Rosario, Santa Fe, Argentina
Sao Paulo, São Paulo, Brazil
Vitória, Espírito Santo, Brazil
Curitiba, Paraná, Brazil
Rio Grande City, Texas, United States
Santa Rosa, California, United States
Englewood, Colorado, United States
Shinjuku Ku, Tokyo, Japan
Rio De Janeiro, , Brazil
Oaxaca De Juarez, Oaxaca, Mexico
San Antonio, Texas, United States
Namdong Gu, Incheon Gwangyeoksi [Incheon], Korea, Republic Of
Barcelona, Catalunya [Cataluña], Spain
Bruce, Australian Capital Territory, Australia
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Mesa, Arizona, United States
Tucson, Arizona, United States
Aurora, Colorado, United States
Miami, Florida, United States
Pensacola, Florida, United States
Bolivar, Missouri, United States
Lima, Ohio, United States
Obu, Aichi, Japan
Itabashi, Tokyo, Japan
Shinjuku, Tokyo, Japan
Tokyo, , Japan
Chuo Ku, Tokyo, Japan
Monterrey, Nuevo León, Mexico
Knoxville, Tennessee, United States
Barcelona, Catalunya [Cataluña], Spain
Passo Fundo, Rio Grande Do Sul, Brazil
Chandler, Arizona, United States
Portland, Oregon, United States
Hoboken, New Jersey, United States
Naples, Florida, United States
Beijing, Beijing, China
Beijing, Beijing, China
Changchun, Jilin, China
Xianyang, Shaanxi, China
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seville, Andalucía, Spain
Barcelona, Barcelona [Barcelona], Spain
San Sebastián, País Vasco, Spain
New Taipei City, New Taipei, Taiwan
Douliu City, Yunlin, Taiwan
New Taipei, , Taiwan
Herston, Queensland, Australia
Sao Paulo, São Paulo, Brazil
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Himeji, Hyogo, Japan
Round Rock, Texas, United States
Santa Fe, , Argentina
Sao Bernardo Do Campo, São Paulo, Brazil
Xian, Shaanxi, China
New Taipei City, New Taipei, Taiwan
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Tampa, Florida, United States
Georgetown, Texas, United States
Rio De Janeiro, , Brazil
Columbus, Georgia, United States
Sherman Oaks, California, United States
Long Beach, California, United States
Decatur, Georgia, United States
Baltimore, Maryland, United States
Dorchester, Massachusetts, United States
Huntington Beach, California, United States
San Juan, , Puerto Rico
Shanghai, Shanghai, China
Wonju, Kang Won Do, Korea, Republic Of
Albuquerque, New Mexico, United States
Hangzhou, Zhejiang, China
Cheng Du, Sichuan, China
Suwon, Kyǒnggi Do, Korea, Republic Of
The Villages, Florida, United States
Fukuoka, , Japan
Marília, São Paulo, Brazil
Southampton, Hampshire, United Kingdom
Ciudad De Buenos Aires, Buenos Aires, Argentina
Chicoutimi, Quebec, Canada
New Taipei City, New Taipei, Taiwan
Shanghai, Shanghai, China
Valinhos, São Paulo, Brazil
Lady Lake, Florida, United States
Clermont, Florida, United States
Greenfield Park, Quebec, Canada
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Deagu, Taegu Kwangyǒkshi, Korea, Republic Of
Melbourne, Florida, United States
Shinjuku Ku, Tokyo, Japan
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Gangnam Gu, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Shinjuku Ku, Tokyo, Japan
Gwangju Si, Kwangju Kwangyǒkshi, Korea, Republic Of
Mount Dora, Florida, United States
Nedlands, Western Australia, Australia
Chicago, Illinois, United States
Romsey, England, United Kingdom
Cheadle, Staffordshire, United Kingdom
Rio De Janeiro, , Brazil
Indianapolis, Indiana, United States
Bunkyo Ku, Tokyo, Japan
Herston, Queensland, Australia
São José Dos Campos, São Paulo, Brazil
Buenos Aires, , Argentina
Guadalajara, Jalisco, Mexico
Redruth, Cornwall, United Kingdom
Guadajalara, Jalisco, Mexico
Victoriaville, Quebec, Canada
Orlando, Florida, United States
Sao Paulo, São Paulo, Brazil
Arlington, Virginia, United States
Victoriaville, Quebec, Canada
Ciudad Autónoma De Buenos Aires, , Argentina
Buenos Aires, , Argentina
Dearborn, Michigan, United States
Brasília, Distrito Federal, Brazil
Las Vegas, Nevada, United States
Newcastle Upon Tyne, , United Kingdom
Tampa, Florida, United States
Montreal, Quebec, Canada
Chuo Ku, Tokyo, Japan
Lake Charles, Louisiana, United States
Charlotte, North Carolina, United States
Hialeah, Florida, United States
Inglewood, California, United States
Riverside, California, United States
San Marcos, California, United States
Davie, Florida, United States
Maitland, Florida, United States
The Villages, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Hattiesburg, Mississippi, United States
Ridgewood, New Jersey, United States
Dallas, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Córdoba, , Argentina
East Maitland, New South Wales, Australia
Macquarie Park, New South Wales, Australia
Birtinya, Queensland, Australia
Herston, Queensland, Australia
South Brisbane, Queensland, Australia
Norwood, South Australia, Australia
Fortaleza, Ceará, Brazil
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Maringá, Paraná, Brazil
Joinville, Santa Catarina, Brazil
Aracaju, Sergipe, Brazil
São Bernardo Do Campo, São Paulo, Brazil
São Paulo, , Brazil
West Vancouver, British Columbia, Canada
Lévis, Quebec, Canada
Montréal, Quebec, Canada
Guangzhou, Guangdong, China
Shanghai, Shanghai, China
Takatsuki Shi, Osaka, Japan
Wako, Saitama, Japan
Tachikawa, Tokyo, Japan
Tokyo, , Japan
Tokyo, , Japan
Jeju Si, Jeju Teukbyeoljachido [Jeju], Korea, Republic Of
Gangseo Gu, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Monterrey, Nuevo León, Mexico
Aguascalientes, , Mexico
Bath, Bath And North East Somerset, United Kingdom
Plymouth, Devon, United Kingdom
Edinburgh, Edinburgh, City Of, United Kingdom
London, London, City Of, United Kingdom
West Kirby, Wirral, United Kingdom
Porto Algre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
Imabari, Ehime, Japan
Hakata Ku, Fukuoka, Japan
Setagaya Ku, Tokyo, Japan
Chiba, , Japan
Osaka, , Japan
Aguascalientes, , Mexico
Barcelona, Barcelona [Barcelona], Spain
Manchester, , United Kingdom
Quincy, Massachusetts, United States
Fujisawa, Kanagawa, Japan
Fukuoka, , Japan
New Taipei City, New Taipei, Taiwan
Edinburgh, Edinburgh, City Of, United Kingdom
Motherwell, Great Britain, 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