A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
- Registration Number
- NCT05026866
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD). Approximately 800 additional participants will be enrolled in a 12-month addendum to assess safety of a different titration regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2996
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo is administered intravenously Donanemab Donanemab Donanemab administered intravenously (IV)
- Primary Outcome Measures
Name Time Method Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS) Estimated Up to Week 182 Time to clinical progression as measured by CDR-GS. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of AD dementia.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Face Name Association Test (FNAME) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by FNAME in participants with preclinical AD.
Change from Baseline in Cogstate Brief Battery (CBB) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by CBB in participants with preclinical AD.
Change from Baseline in Montreal Cognitive Assessment (MoCA) score Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by MoCA score in participants with preclinical AD.
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs) Baseline through Week 16 Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by BPS-O in participants with preclinical AD.
Change from Baseline in Cognitive Function Index (CFI) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by CFI in participants with preclinical AD.
Change from Baseline in International Shopping List Test (ISLT) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by ISLT in participants with preclinical AD.
Change from Baseline in Continuous Paired Associate Learning (CPAL) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by CPAL in participants with preclinical AD.
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by iDSSTm in participants with preclinical AD.
Change from Baseline in Category Fluency Baseline, Up to Week 182 Change from Baseline in clinical progression as measured by Category Fluency in participants with preclinical AD.
Change from Baseline in CDR-Sum of Boxes (CDR-SB) Baseline, Up Week 32 Change from Baseline in clinical progression as measured by CDR-SB in participants with preclinical AD.
Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State Baseline through Week 76 PK: Average Serum Donanemab Concentration at Steady State
Trial Locations
- Locations (213)
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive
🇺🇸Homewood, Alabama, United States
Rehabilitation & Neurological Services
🇺🇸Huntsville, Alabama, United States
Care Access - 801 South Power Road, Mesa
🇺🇸Mesa, Arizona, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Banner Alzheimer's Institute Tucson
🇺🇸Tucson, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Care Access - Berkeley
🇺🇸Berkeley, California, United States
Care Access - Beverly Hills
🇺🇸Beverly Hills, California, United States
Velocity Clinical Research, Chula Vista
🇺🇸Chula Vista, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Care Access - Gilroy
🇺🇸Gilroy, California, United States
Care Access Research - Huntington Beach
🇺🇸Huntington Beach, California, United States
Irvine Clinical Research
🇺🇸Irvine, California, United States
Option Care - Irvine
🇺🇸Irvine, California, United States
Kaizen Brain Center
🇺🇸La Jolla, California, United States
Velocity Clinical Research, San Diego
🇺🇸La Mesa, California, United States
Pacific Research Network
🇺🇸Lemon Grove, California, United States
Healthy Brain Clinic
🇺🇸Long Beach, California, United States
Neurovations
🇺🇸Napa, California, United States
Care Access - Newport Beach
🇺🇸Newport Beach, California, United States
Inland Psychiatric Medical Group
🇺🇸Redlands, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Option Care - Riverside
🇺🇸Riverside, California, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Ray Dolby Brain Health Center
🇺🇸San Francisco, California, United States
Care Access - Los Gatos
🇺🇸San Jose, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Care Access - Santa Clarita
🇺🇸Santa Clarita, California, United States
Option Care - Los Angeles South
🇺🇸Santa Fe Springs, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Mazur, Statner, Dutta, Nathan, PC
🇺🇸Thousand Oaks, California, United States
Tilda Research
🇺🇸Tustin, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Van Nuys, California, United States
Infectious Disease Doctors Medical Group, APC
🇺🇸Walnut Creek, California, United States
Care Access - Aurora
🇺🇸Aurora, Colorado, United States
Mountain Neurological Research Center
🇺🇸Basalt, Colorado, United States
Denver Neurological Research
🇺🇸Denver, Colorado, United States
Invicro
🇺🇸New Haven, Connecticut, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
VIN-Julie Schwartzbard
🇺🇸Aventura, Florida, United States
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
SFM Clinical Research
🇺🇸Boca Raton, Florida, United States
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
Care Access - Daytona Beach
🇺🇸Daytona Beach, Florida, United States
Care Access - Delray Beach
🇺🇸Delray Beach, Florida, United States
Finlay Medical Research
🇺🇸Miami, Florida, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Infinity Clinical Research, LLC
🇺🇸Hollywood, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Care Access - Guava Street
🇺🇸Lady Lake, Florida, United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
🇺🇸Largo, Florida, United States
ClinCloud - Maitland
🇺🇸Maitland, Florida, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
ClinCloud - Viera
🇺🇸Melbourne, Florida, United States
Merritt Island Medical Research, LLC
🇺🇸Merritt Island, Florida, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami Lakes, Florida, United States
South Florida Research Phase I-IV
🇺🇸Miami Springs, Florida, United States
Optimus U Corporation
🇺🇸Miami, Florida, United States
VIN-Andrew Lerman
🇺🇸Miami, Florida, United States
Brainstorm Research Group
🇺🇸Miami, Florida, United States
IMIC, Inc.
🇺🇸Miami, Florida, United States
VIN-Victor Faradji
🇺🇸Miami, Florida, United States
Adult Medicine of Lake County
🇺🇸Mount Dora, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Headlands Research Orlando
🇺🇸Orlando, Florida, United States
Pines Care Research Center, LLC
🇺🇸Pembroke Pines, Florida, United States
VIN- Margarita Almeida El-Ramey
🇺🇸Pembroke Pines, Florida, United States
Emerald Coast Neurology - Airport Boulevard
🇺🇸Pensacola, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Care Access - Sun City Center - Cypress Village Boulevard
🇺🇸Sun City Center, Florida, United States
Care Access - Tamarac
🇺🇸Tamarac, Florida, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
K2 Medical Research - Tampa
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Vicis Clinical Research
🇺🇸Tampa, Florida, United States
Coram CVS/Specialty Infusion Services - Tampa
🇺🇸Tampa, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Masters of Clinical Research
🇺🇸Augusta, Georgia, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Center for Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
SKY Clinical Research Network Group-Blake
🇺🇸Union City, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
IMA Clinical Research - Chicago
🇺🇸Chicago, Illinois, United States
Neurological Associates Albany
🇺🇸Albany, New York, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials - Andersonville
🇺🇸Chicago, Illinois, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
🇺🇸Elk Grove Village, Illinois, United States
Care Access - Fairview Heights
🇺🇸Fairview Heights, Illinois, United States
Great Lakes Clinical Trials - Gurnee
🇺🇸Gurnee, Illinois, United States
Accellacare - DuPage
🇺🇸Lombard, Illinois, United States
Coram CVS/Specialty Infusion Services - Fort Wayne
🇺🇸Fort Wayne, Indiana, United States
Care Access - South Indianapolis
🇺🇸Indianapolis, Indiana, United States
Josephson Wallack Munshower Neurology, PC
🇺🇸Indianapolis, Indiana, United States
Covenant Medical Center
🇺🇸Waterloo, Iowa, United States
College Park Specialty Center
🇺🇸Overland Park, Kansas, United States
Norton Brownsboro Hospital
🇺🇸Louisville, Kentucky, United States
Optum Infusion - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Care Access - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
ActivMed Practices and Research
🇺🇸Methuen, Massachusetts, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Care Access - Quincy
🇺🇸Quincy, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Revival Research Institute
🇺🇸Southfield, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville Office
🇺🇸Burnsville, Minnesota, United States
Coram CVS/Specialty Infusion Services - Mendota Heights
🇺🇸Mendota Heights, Minnesota, United States
SKY Clinical Research Network Group - Hall
🇺🇸Fayette, Mississippi, United States
SKY Clinical Research Network Group-Quinn
🇺🇸Ridgeland, Mississippi, United States
Citizens Memorial Hospital District
🇺🇸Bolivar, Missouri, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
IMA Clinical Research - St. Louis
🇺🇸Saint Louis, Missouri, United States
Coram CVS/Specialty Infusion Services - Henderson
🇺🇸Henderson, Nevada, United States
Option Care - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
IMA Clinical Research Hoboken
🇺🇸Hoboken, New Jersey, United States
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
IMA Clinical Research Warren
🇺🇸Warren, New Jersey, United States
Albuquerque Neuroscience Inc.
🇺🇸Albuquerque, New Mexico, United States
IMA Clinical Research Albany
🇺🇸Albany, New York, United States
Prime Global Research
🇺🇸Bronx, New York, United States
Velocity Clinical Research, Syracuse
🇺🇸East Syracuse, New York, United States
IMA Clinical Research Westchester
🇺🇸Hartsdale, New York, United States
IMA Clinical Research
🇺🇸New York, New York, United States
South Shore Neurologic Associates
🇺🇸Patchogue, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Asheville Neurology Specialists
🇺🇸Asheville, North Carolina, United States
Care Access - Charlotte
🇺🇸Charlotte, North Carolina, United States
Care Access - Fayetteville
🇺🇸Fayetteville, North Carolina, United States
Care Access - Greensboro
🇺🇸Greensboro, North Carolina, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States
Care Access - Kinston
🇺🇸Kinston, North Carolina, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Care Access - Raleigh
🇺🇸Raleigh, North Carolina, United States
Accellacare - Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
NeuroScience Research Center
🇺🇸Canton, Ohio, United States
Hometown Urgent Care and Research - Cincinnati
🇺🇸Dayton, Ohio, United States
Neurology Diagnostics, Inc.
🇺🇸Dayton, Ohio, United States
Care Access - Lima
🇺🇸Lima, Ohio, United States
North Star Medical Research
🇺🇸Middleburg Heights, Ohio, United States
Care Access - Youngstown
🇺🇸Poland, Ohio, United States
Central States Research
🇺🇸Tulsa, Oklahoma, United States
Optum Infusion - Bend
🇺🇸Bend, Oregon, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Center for Cognitive Health
🇺🇸Portland, Oregon, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Care Access - Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Care Access Research - Warwick
🇺🇸Warwick, Rhode Island, United States
Care Access - Anderson
🇺🇸Anderson, South Carolina, United States
Velocity Clinical Research, Anderson
🇺🇸Anderson, South Carolina, United States
VitaLink Research - Columbia
🇺🇸Columbia, South Carolina, United States
Velocity Clinical Research, Gaffney
🇺🇸Gaffney, South Carolina, United States
VitaLink Research - Greenville
🇺🇸Greenville, South Carolina, United States
Care Access - Mauldin
🇺🇸Mauldin, South Carolina, United States
VitaLink Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
VitaLink Research - Union
🇺🇸Union, South Carolina, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Neurology Clinic
🇺🇸Cordova, Tennessee, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Headlands Research - Brownsville
🇺🇸Brownsville, Texas, United States
Conroe Willis Medical Research
🇺🇸Conroe, Texas, United States
Advanced Neuro Research Center - ANRC
🇺🇸El Paso, Texas, United States
Care Access - Georgetown
🇺🇸Georgetown, Texas, United States
Optum Infusion - Houston
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
Family Practice Center
🇺🇸McAllen, Texas, United States
El Faro Health and Therapeutics
🇺🇸Rio Grande City, Texas, United States
Benchmark Research - Knickerbocker
🇺🇸San Angelo, Texas, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Texas Valley Clinical Research
🇺🇸Weslaco, Texas, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Care Access - Arlington
🇺🇸Arlington, Virginia, United States
Option Care - Chantilly
🇺🇸Chantilly, Virginia, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Universal Research Group
🇺🇸Tacoma, Washington, United States
Optum Infusion - Woodinville
🇺🇸Woodinville, Washington, United States
Exemplar Research
🇺🇸Morgantown, West Virginia, United States
National Center for Geriatrics and Gerontology
🇯🇵Obu, Aichi, Japan
Oita University Hospital
🇯🇵Yufu, Oita, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
P-One Clinic
🇯🇵Hachioji, Tokyo, Japan
Tokyo Metropolitan Geriatric Hospital
🇯🇵Itabashi, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Samoncho Clinic
🇯🇵Shinjuku, Tokyo, Japan
Instituto De Neurologia Dra. Ivonne Fraga
🇵🇷San Juan, Puerto Rico
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility
🇵🇷San Juan, Puerto Rico
AMC Nishiumeda Clinic
🇯🇵Osaka, Japan
Tokyo Asbo Clinic
🇯🇵Tokyo, Japan
SCB Research Center
🇵🇷Bayamon, Puerto Rico
Dr. Samuel Sanchez PSC
🇵🇷Caguas, Puerto Rico
INSPIRA Clinical Research
🇵🇷San Juan, Puerto Rico