A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
3 other identifiers
interventional
1,736
9 countries
274
Brief Summary
The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Jun 2020
Longer than P75 for phase_3 alzheimer-disease
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2023
CompletedResults Posted
Study results publicly available
May 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
ExpectedAugust 29, 2025
August 1, 2025
2.8 years
June 17, 2020
April 10, 2024
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor (AchI)/Memantine use.
Baseline, Week 76
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Baseline, Week 76
Secondary Outcomes (13)
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)
Baseline, Week 76
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)
Baseline, Week 76
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
Baseline, Week 76
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
Baseline, Week 76
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)
Baseline, Week 76
- +8 more secondary outcomes
Study Arms (2)
Donanemab
EXPERIMENTALParticipants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
Placebo
PLACEBO COMPARATORParticipants received placebo given IV.
Interventions
Eligibility Criteria
You may qualify if:
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 20 to 28 (inclusive) at baseline
- Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
- Meet 18F florbetapir PET scan (central read) criteria
- Have a study partner who will provide written informed consent to participate
You may not qualify if:
- Contraindication to MRI or PET scans
- Current treatment with immunoglobulin G (IgG) therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (274)
Gilbert Neurology
Gilbert, Arizona, 85297, United States
Xenoscience
Phoenix, Arizona, 85004, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Banner Alzheimer's Institute Tucson
Tucson, Arizona, 85718, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Health Initiatives Research
Fayetteville, Arkansas, 72703, United States
North County Neurology Associates
Carlsbad, California, 92011, United States
Wr- Pri, Llc
Encino, California, 91316, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Kaizen Brain Center
La Jolla, California, 92037, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
USC Keck School of Medicine
Los Angeles, California, 90033, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
Neurovations
Napa, California, 94558, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
SC3 Research - Pasadena
Pasadena, California, 91105, United States
PCND Neurology
Poway, California, 92064, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Pacific Research Network
San Diego, California, 92103, United States
Sharp Neurocognitive Research Center
San Diego, California, 92123, United States
UCSF Memory and Aging Center
San Francisco, California, 94158, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Tilda Research
Tustin, California, 92780, United States
Mountain Neurological Research Center
Basalt, Colorado, 81621, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Colorado Neurological Research Center, PC
Denver, Colorado, 80210, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Yale University, Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510, United States
Research Center for Clinical Studies
Norwalk, Connecticut, 06851, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
SFM Clinical Research
Boca Raton, Florida, 33487, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Cohen Medical Associates
Delray Beach, Florida, 33446, United States
Integrity Clinical Research
Doral, Florida, 33166, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
MD Clinical
Hallandale, Florida, 33009, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
Encore Research Group- Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, 33803, United States
ClinCloud - Maitland
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Homestead Associates in Research
Miami, Florida, 33032, United States
Finlay Medical Research
Miami, Florida, 33126, United States
Optimus U Corporation
Miami, Florida, 33135, United States
Miami Jewish health
Miami, Florida, 33137, United States
Future Care Solution
Miami, Florida, 33142, United States
Allied Biomedical Research Institute
Miami, Florida, 33155, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Florida International Research Center
Miami, Florida, 33173, United States
Ezy Medical Research
Miami, Florida, 33175, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
The Neurology Research Group
Miami, Florida, 33176, United States
VIN-Victor Faradji
Miami, Florida, 33176, United States
Mount Sinai Cancer Center
Miami Beach, Florida, 33140, United States
Goji Group - Research Trials Group
Miami Lakes, Florida, 33016, United States
Collier Neurologic Specialists
Naples, Florida, 34105, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Synexus Clinical Research US, Inc.
Orlando, Florida, 32806, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
IMIC, Inc.
Palmetto Bay, Florida, 33157, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504, United States
Quantum Laboratories Clinical Research
Pompano Beach, Florida, 33064, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Roskamp Institute Clinical Trials Division
Sarasota, Florida, 34243, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, 34997, United States
Brain Matters Research
Stuart, Florida, 34997, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
USF Health Byrd Alzheimer's Institute
Tampa, Florida, 33613, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162, United States
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Conquest Research
Winter Park, Florida, 32789, United States
Charter Research - Winter Park
Winter Park, Florida, 32803, United States
Gwinnett Research Institute
Buford, Georgia, 30519, United States
Columbus Memory Center, LLC
Columbus, Georgia, 31909, United States
NeuroStudies
Decatur, Georgia, 30030, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, 60007, United States
Advocate Medical Group
Park Ridge, Illinois, 60068, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205, United States
College Park Family Care Center/Multi Specialty Clinical Res
Overland Park, Kansas, 66212, United States
Cotton O'Neil Clinical Research Center - Central Office
Topeka, Kansas, 66606, United States
Ascension Via Christi Research
Wichita, Kansas, 67214, United States
Maine Medical Center-Maine Medical Partners Neurology
Scarborough, Maine, 04074, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
BTC Network
New Bedford, Massachusetts, 02740, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Donald S. Marks M.D., P.C.
Plymouth, Massachusetts, 02360, United States
Alzheimers Disease Center
Quincy, Massachusetts, 02169, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Sharlin Health and Neurology
Ozark, Missouri, 65721, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albany Medical College
Albany, New York, 12208, United States
Neurological Associates Albany
Albany, New York, 12208, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
University at Buffalo - UBMD Neurology
Buffalo, New York, 14203, United States
Clarity Clinical Research
East Syracuse, New York, 13057, United States
NYU Langone Health
New York, New York, 10016, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
CHS-Behavioral Health Research
Charlotte, North Carolina, 28211, United States
Guilford Neurologic Associates, Inc
Greensboro, North Carolina, 27405, United States
AMC Research
Matthews, North Carolina, 28105, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
NeuroScience Research Center
Canton, Ohio, 44718, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Cincinnati Physicians Company, LLC
Dayton, Ohio, 45417, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Summit Headlands
Portland, Oregon, 97210, United States
Center for Cognitive Health
Portland, Oregon, 97225, United States
Abington Neurological Associates, Ltd.
Abington, Pennsylvania, 19001, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Prism Health Richland Department of Neurology Research
Columbia, South Carolina, 29203, United States
Neurology Clinic, P.C.
Cordova, Tennessee, 38018, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Kerwin Medical Center
Dallas, Texas, 75231, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681, United States
Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases
San Antonio, Texas, 78229-3900, United States
The Memory Clinic
Bennington, Vermont, 05201-9810, United States
Integrated Neurology Services - Falls Church
Arlington, Virginia, 22207, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23510, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
EvergreenHealth Medical Center
Kirkland, Washington, 98034, United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104, United States
Kingfisher Cooperative
Spokane, Washington, 99201, United States
Universal Research Group
Tacoma, Washington, 98405, United States
Central Coast Neurosciences Research
Erina, New South Wales, 2250, Australia
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
HammondCare Greenwich Hospital
Sydney, New South Wales, 2065, Australia
KARA Institute for Neurological Diseases
Sydney, New South Wales, 2113, Australia
NeuroCentrix
Carlton, Victoria, 3053, Australia
Delmont Private Hospital
Glen Iris, Victoria, 3146, Australia
HammondCare
Malvern, Victoria, 3144, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
OCT Research ULC
Kelowna, British Columbia, V1Y 1Z9, Canada
True North Clinical Research
Halifax, Nova Scotia, B3S 1N2, Canada
True North Clinical Research
New Minas, Nova Scotia, B4N 3R7, Canada
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Bruyère Research Institute
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1, Canada
Clinique de la Mémoire de l'Outaouais
Gatineau, Quebec, K1Z 1G3, Canada
MoCA Research and Innovation Inc.
Greenfield Park, Quebec, J4V 2J2, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1J 2G2, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Clinline Services
Hostivice, Central Bohemia, 253 01, Czechia
Brain-Soul Therapy
Kladno, Central Bohemia, 272 01, Czechia
A-Shine
Pilsen, Plzeň-město, 30100, Czechia
Clintrial s.r.o.
Prague, Praha 10, 100 00, Czechia
Neurologická Ambulance - Forbeli
Prague, Praha 6, 160 00, Czechia
Neuropsychiatrie
Prague, Praha 6, 160 00, Czechia
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, 454-8502, Japan
Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530, Japan
Kojunkai Daido Clinic
Nagoya, Aichi-ken, 4570818, Japan
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, 474-8511, Japan
Inage Neurology and Memory Clinic
Inage, Chiba, 263-0043, Japan
Matsui e-clinic
Akashi, Hyōgo, 673-0891, Japan
Himeji Central Hospital Affiliated Clinic
Himeji, Hyōgo, 672-8043, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kakigi Dementia Happiness Clinic
Kobe, Hyōgo, 657-0825, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki, Ibaraki, 300-0332, Japan
Memory Clinic Toride
Toride, Ibaraki, 302-0004, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-0801, Japan
Oita University Hospital
Yufu, Oita Prefecture, 879-5593, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, 710-0813, Japan
Honmachi Clinic
Ikeda, Osaka, 563-0058, Japan
Takatsuki General Hospital
Takatsuki, Osaka, 569-1192, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028, Japan
Moriyama Neuro Center Hospital
Edogawa-ku, Tokyo, 134-0088, Japan
P-One Clinic
Hachiōji, Tokyo, 192-0071, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, 162-0053, Japan
Tokyo Metro Bokutoh Hospital
Sumida-ku, Tokyo, 130-0022, Japan
Hiroshima Neurology Clinic
Hiroshima, 732-0822, Japan
Koseikai Takeda Hospital
Kyoto, 600-8558, Japan
Ishikawa Clinic
Kyoto, 606-0851, Japan
National hospital Organization Utano National Hospital
Kyoto, 616-8255, Japan
Oita Prefectural Hospital
Ōita, 870-0855, Japan
Itsuki Hospital
Tokushima, 770-0852, Japan
Tokyo Asbo Clinic
Tokyo, 104-0031, Japan
Nippon Medical School Hospital
Tokyo, 113-8603, Japan
Makita General Hospital
Tokyo, 143-0016, Japan
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, North Brabant, 5223 LA, Netherlands
Brain Research Center
Amsterdam, North Holland, 1081 GN, Netherlands
Brain Research Center Zwolle
Zwolle, Overijssel, 8025 AZ, Netherlands
QPS Netherlands B.V
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, Greater Poland Voivodeship, 61-853, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland
Diamond Clinic
Krakow, Lesser Poland Voivodeship, 31-559, Poland
Ośrodek Badawczo Naukowo Dydaktyczny Chorób Otępiennych Im Księdza Henryka Kardynała Gulbinowicza Uniwersy -T
Ścinawa, Lower Silesian Voivodeship, 59-330, Poland
Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, 53-659, Poland
Private Practice - Dr. Urszula Chyrchel- Paszkiewicz
Lublin, Lublin Voivodeship, 20-093, Poland
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, 00-215, Poland
Centrum Medyczne NeuroProtect
Warsawawa, Masovian Voivodeship, 01-684, Poland
KLIMED Marek Klimkiewicz
Bialystok, Podlaskie Voivodeship, 15-704, Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Podlaskie Voivodeship, 15-756, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne SENIOR
Sopot, Pomeranian Voivodeship, 81-855, Poland
Klinika Neuro-Care
Katowice, Silesian Voivodeship, 40-749, Poland
Centrum Medyczne Euromedis
Szczecin, West Pomeranian Voivodeship, 70-111, Poland
SCB Research Center
Bayamón, 00961, Puerto Rico
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918, Puerto Rico
Barbara Diaz-Hernandez MD Research, Inc.
San Juan, 00926, Puerto Rico
Glasgow Memory Clinic
Motherwell, Great Britain, ML1 4UF, United Kingdom
Re:Cognition Health - London
London, London, City of, W1G 9JF, United Kingdom
Re:Cognition Health Guildford
Guildford, Surrey, GU2 7YD, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, B16 8LT, United Kingdom
Related Publications (9)
Zimmer JA, Sims JR, Evans CD, Nery ESM, Wang H, Wessels AM, Tronchin G, Sato S, Raket LL, Andersen SW, Sapin C, Paget MA, Gueorguieva I, Ardayfio P, Khanna R, Brooks DA, Matthews BR, Mintun MA; Alzheimer's Disease Neuroimaging Initiative. Donanemab in early symptomatic Alzheimer's disease: results from the TRAILBLAZER-ALZ 2 long-term extension. J Prev Alzheimers Dis. 2026 Feb;13(2):100446. doi: 10.1016/j.tjpad.2025.100446. Epub 2025 Dec 1.
PMID: 41330788DERIVEDLu M, Kim MJ, Collins EC, Shcherbinin S, Ellinwood AK, Yokoi Y, Brooks DA, Hansson O, Knopman DS, Sims JR, Mintun MA. Posttreatment Amyloid Levels and Clinical Outcomes Following Donanemab for Early Symptomatic Alzheimer Disease: A Secondary Analysis of the TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1251-1256. doi: 10.1001/jamaneurol.2025.3869.
PMID: 41082199DERIVEDChandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
PMID: 40603145DERIVEDZimmer JA, Ardayfio P, Wang H, Khanna R, Evans CD, Lu M, Sparks J, Andersen S, Lauzon S, Nery ESM, Battioui C, Engle SE, Biffi A, Svaldi D, Salloway S, Greenberg SM, Sperling RA, Mintun M, Brooks DA, Sims JR. Amyloid-Related Imaging Abnormalities With Donanemab in Early Symptomatic Alzheimer Disease: Secondary Analysis of the TRAILBLAZER-ALZ and ALZ 2 Randomized Clinical Trials. JAMA Neurol. 2025 May 1;82(5):461-469. doi: 10.1001/jamaneurol.2025.0065.
PMID: 40063015DERIVEDBoustani M, Doty EG, Garrison LP Jr, Smolen LJ, Klein TM, Murphy DR, Spargo AW, Belger M, Johnston JA. Estimating the Economically Justifiable Price of Limited-Duration Treatment with Donanemab for Early Symptomatic Alzheimer's Disease in the United States. Neurol Ther. 2024 Dec;13(6):1641-1659. doi: 10.1007/s40120-024-00649-y. Epub 2024 Sep 18.
PMID: 39292433DERIVEDSato S, Hatakeyama N, Fujikoshi S, Katayama S, Katagiri H, Sims JR. Donanemab in Japanese Patients with Early Alzheimer's Disease: Subpopulation Analysis of the TRAILBLAZER-ALZ 2 Randomized Trial. Neurol Ther. 2024 Jun;13(3):677-695. doi: 10.1007/s40120-024-00604-x. Epub 2024 Apr 6.
PMID: 38581616DERIVEDKlein EG, Schroeder K, Wessels AM, Phipps A, Japha M, Schilling T, Zimmer JA. How donanemab data address the coverage with evidence development questions. Alzheimers Dement. 2024 Apr;20(4):3127-3140. doi: 10.1002/alz.13700. Epub 2024 Feb 7.
PMID: 38323738DERIVEDSims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, Wessels AM, Shcherbinin S, Wang H, Monkul Nery ES, Collins EC, Solomon P, Salloway S, Apostolova LG, Hansson O, Ritchie C, Brooks DA, Mintun M, Skovronsky DM; TRAILBLAZER-ALZ 2 Investigators. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239.
PMID: 37459141DERIVEDBrodtmann A, Darby D, Oboudiyat C, Mahoney CJ, Le Heron C, Panegyres PK, Brew B. Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust. 2023 Apr 3;218(6):247-249. doi: 10.5694/mja2.51880. Epub 2023 Mar 19. No abstract available.
PMID: 36934371DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 18, 2020
Study Start
June 19, 2020
Primary Completion
April 14, 2023
Study Completion (Estimated)
November 1, 2028
Last Updated
August 29, 2025
Results First Posted
May 20, 2024
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.