A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
Launched by ELI LILLY AND COMPANY · Aug 27, 2021
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The TRAILBLAZER-ALZ 3 study is a clinical trial focused on testing the safety and effectiveness of a drug called donanemab in people who have early signs of Alzheimer's disease but do not yet have noticeable symptoms. Researchers aim to enroll about 800 participants to help gather more information about the drug over a 12-month period. To be eligible for this study, participants must show that they have normal cognitive abilities through a specific test, and they need to have certain biological markers that suggest early signs of Alzheimer's. It’s also important that they have someone reliable, like a family member or friend, who can help provide information about their daily activities and mental state.
If you decide to participate, you'll undergo some tests to ensure you're a good fit for the study, and you’ll be monitored closely for any side effects or changes in your health. This trial is currently recruiting participants of all genders between the ages of 23 and 29, and it’s crucial that those interested do not have any significant cognitive impairments or serious health conditions that could interfere with the study. Overall, this trial aims to better understand how donanemab can help those at risk of developing Alzheimer's, with hopes of improving future treatments.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
- • Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
- • Has 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.
- • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- • Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.
- Exclusion Criteria:
- • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
- • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.
- • History of cancer with high risk of recurrence and preventing completion of the trial.
- • History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
- • Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
- • Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- • Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), \>4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
- • Have had prior treatment with a passive anti-amyloid immunotherapy \<5 half-lives prior to randomization.
- • Have received active immunization against amyloid beta (Aβ) in any other study.
- • Have received active immunization against Aβ in any other study.
- • Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.
- Addendum 7 Exclusion Criteria for Clinicaltrials.gov:
- • Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.
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
Los Angeles, California, United States
Elk Grove Village, Illinois, United States
Houston, Texas, United States
San Diego, California, United States
Chicago, Illinois, United States
Phoenix, Arizona, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Saginaw, Michigan, United States
Kansas City, Missouri, United States
Redlands, California, United States
Waterloo, Iowa, United States
Phoenix, Arizona, United States
Jenkintown, Pennsylvania, United States
Media, Pennsylvania, United States
Tampa, Florida, United States
Austin, Texas, United States
New Port Richey, Florida, United States
San Antonio, Texas, United States
Staten Island, New York, United States
Birmingham, Alabama, United States
Bradenton, Florida, United States
Woodstock, Georgia, United States
Oxon Hill, Maryland, United States
Rapid City, South Dakota, United States
Boise, Idaho, United States
Asheville, North Carolina, United States
Bunkyo Ku, Tokyo, Japan
San Juan, , Puerto Rico
Tampa, Florida, United States
Fullerton, California, United States
Tampa, Florida, United States
Atlantis, Florida, United States
Yufu, Oita, Japan
Chicago, Illinois, United States
Bellevue, Washington, United States
Port Orange, Florida, United States
Tucson, Arizona, United States
Albuquerque, New Mexico, United States
Memphis, Tennessee, United States
Tacoma, Washington, United States
Cordova, Tennessee, United States
San Juan, , Puerto Rico
Patchogue, New York, United States
Napa, California, United States
Newton, Massachusetts, United States
Boca Raton, Florida, United States
Middleburg Heights, Ohio, United States
Northridge, California, United States
Morehead City, North Carolina, United States
Decatur, Georgia, United States
San Diego, California, United States
Indianapolis, Indiana, United States
Greensboro, North Carolina, United States
Richmond, Virginia, United States
Savannah, Georgia, United States
Sacramento, California, United States
Miami, Florida, United States
Santa Ana, California, United States
Osaka, , Japan
Tulsa, Oklahoma, United States
Chuo Ku, Tokyo, Japan
Palmetto Bay, Florida, United States
Tampa, Florida, United States
San Juan, , Puerto Rico
Las Vegas, Nevada, United States
Ocala, Florida, United States
Miami Springs, Florida, United States
San Francisco, California, United States
Gainesville, Georgia, United States
Memphis, Tennessee, United States
Louisville, Kentucky, United States
Las Vegas, Nevada, United States
Boca Raton, Florida, United States
Springfield, New Jersey, United States
Huntington Beach, California, United States
Panorama City, California, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Miami, Florida, United States
Chesterfield, Missouri, United States
Denver, Colorado, United States
Hollywood, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Covina, California, United States
Monroe, North Carolina, United States
East Syracuse, New York, United States
New Haven, Connecticut, United States
Winter Park, Florida, United States
Chuo Ku, Tokyo, Japan
Canton, Ohio, United States
Huntington Beach, California, United States
Greenville, South Carolina, United States
Morgantown, West Virginia, United States
Spartanburg, South Carolina, United States
Beaumont, Texas, United States
Medford, Oregon, United States
Waltham, Massachusetts, United States
Caguas, , Puerto Rico
Staten Island, New York, United States
Greenacres City, Florida, United States
Orlando, Florida, United States
Lady Lake, Florida, United States
Miami, Florida, United States
Elk Grove Village, Illinois, United States
Clearwater, Florida, United States
Poland, Ohio, United States
Riverside, California, United States
Hachioji, Tokyo, Japan
Irvine, California, United States
Boca Raton, Florida, United States
Austin, Texas, United States
Methuen, Massachusetts, United States
Suita Shi, Osaka, Japan
La Jolla, California, United States
Gilroy, California, United States
Greensboro, North Carolina, United States
Kinston, North Carolina, United States
Basalt, Colorado, United States
Union, South Carolina, United States
Mcallen, Texas, United States
Shavano Park, Texas, United States
Ridgeland, Mississippi, United States
Irvine, California, United States
Lady Lake, Florida, United States
Merritt Island, Florida, United States
Warwick, Rhode Island, United States
Houston, Texas, United States
Hialeah, Florida, United States
Conroe, Texas, United States
Huntsville, Alabama, United States
Thousand Oaks, California, United States
Walnut Creek, California, United States
Chicago, Illinois, United States
Sterling Heights, Michigan, United States
Denver, Colorado, United States
Aventura, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Albany, New York, United States
Bayamon, , Puerto Rico
Winston Salem, North Carolina, United States
Mount Dora, Florida, United States
Bronx, New York, United States
Chula Vista, California, United States
Medford, Oregon, United States
Memphis, Tennessee, United States
Pembroke Pines, Florida, United States
Shinjuku Ku, Tokyo, Japan
Union City, Georgia, United States
Bellaire, Texas, United States
Raritan, New Jersey, United States
Winter Park, Florida, United States
Rio Grande City, Texas, United States
Cincinnati, Ohio, United States
Santa Rosa, California, United States
Shinjuku Ku, Tokyo, Japan
Union City, Georgia, United States
Pembroke Pines, Florida, United States
La Mesa, California, United States
Anderson, South Carolina, United States
San Juan, , Puerto Rico
Homewood, Alabama, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Bakersfield, California, United States
Berkeley, California, United States
Beverly Hills, California, United States
Irvine, California, United States
Irvine, California, United States
Newport Beach, California, United States
Redlands, California, United States
Riverside, California, United States
San Jose, California, United States
Santa Clarita, California, United States
Santa Fe Springs, California, United States
Aurora, Colorado, United States
Daytona Beach, Florida, United States
Delray Beach, Florida, United States
Lady Lake, Florida, United States
Maitland, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Sun City, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Fairview Heights, Illinois, United States
Gurnee, Illinois, United States
Lombard, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Baton Rouge, Louisiana, United States
Lake Charles, Louisiana, United States
Quincy, Massachusetts, United States
Burnsville, Minnesota, United States
Mendota Heights, Minnesota, United States
Fayette, Mississippi, United States
Bolivar, Missouri, United States
Saint Louis, Missouri, United States
Henderson, Nevada, United States
Hoboken, New Jersey, United States
Albany, New York, United States
East Syracuse, New York, United States
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New York, New York, United States
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Lima, Ohio, United States
Oklahoma City, Oklahoma, United States
Pottsville, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Gaffney, South Carolina, United States
Mauldin, South Carolina, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
San Angelo, Texas, United States
Weslaco, Texas, United States
Salt Lake City, Utah, United States
Bennington, Vermont, United States
Alexandria, Virginia, United States
Chantilly, Virginia, United States
Woodinville, Washington, United States
Morgantown, West Virginia, United States
Obu, Aichi, Japan
Itabashi, Tokyo, Japan
Shinjuku, Tokyo, Japan
Tokyo, , Japan
San Juan, , Puerto Rico
Jacksonville, Florida, United States
Itasca, Illinois, United States
Bend, Oregon, United States
Indianapolis, Indiana, United States
Brownsville, Texas, United States
Georgetown, Texas, United States
Panorama City, California, United States
Sacramento, California, United States
Sauk Rapids, Minnesota, United States
Saint Petersburg, Florida, United States
Las Vegas, Nevada, United States
Everett, Washington, United States
Long Beach, California, United States
Ontario, California, United States
Roseville, Minnesota, United States
Greensboro, North Carolina, United States
Pineville, North Carolina, United States
Milford, Ohio, United States
Spokane Valley, Washington, United States
Charleston, West Virginia, United States
Irving, Texas, United States
Ridgeland, Mississippi, United States
San Diego, California, United States
Jacksonville, Florida, United States
Decatur, Georgia, United States
Warren, New Jersey, United States
Columbia, Maryland, United States
New York, New York, United States
Dorchester, Massachusetts, United States
Huntington Beach, California, United States
Warren, New Jersey, United States
Largo, Florida, United States
Ridgeland, Mississippi, United States
Miami, Florida, United States
Saint Louis, Missouri, United States
Tustin, California, United States
Largo, Florida, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Hartsdale, New York, United States
Tampa, Florida, United States
Tampa, Florida, United States
Fayette, Mississippi, United States
San Juan, , Puerto Rico
The Villages, Florida, United States
Jacksonville, Florida, United States
Homewood, Alabama, United States
Thousand Oaks, California, United States
Walnut Creek, California, United States
Saint Petersburg, Florida, United States
Kinston, North Carolina, United States
Columbia, South Carolina, United States
Tustin, California, United States
Tucson, Arizona, United States
Fayetteville, North Carolina, United States
San Juan, , Puerto Rico
Indianapolis, Indiana, United States
Hoboken, New Jersey, United States
Alexandria, Virginia, United States
Bunkyo Ku, Tokyo, Japan
San Juan, , Puerto Rico
Orlando, Florida, United States
Arlington, Virginia, United States
Cordova, Tennessee, United States
Van Nuys, California, United States
Charlotte, North Carolina, United States
Largo, Florida, United States
Lemon Grove, California, United States
Southfield, Michigan, United States
Quincy, Massachusetts, United States
Miami, Florida, United States
Sun City Center, Florida, United States
Dayton, Ohio, United States
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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