What this study is
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
What's being tested
- Donanemab
Intervention · DRUG
Donanemab administered IV
- Placebo
Intervention · DRUG
Placebo administered IV
Study details
- Official title
- A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
- Sponsor
- Eli Lilly and Company
- Conditions
- Cognitive Dysfunction · Lewy Body Disease · Synucleinopathies · Amyloid
- Enrolling
- 350 people
- Starts
- 2026-05-20
- Est. completion
- 2028-08
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
- Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
- Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
- Meet plasma P-tau217 criteria.
- Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
- Have a CSF result consistent with the presence of alpha-synuclein pathology.
- Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
You can't join if
- Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
- Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
- Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
- Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
- Have previously received amyloid-targeting therapy.
- Active immunization against amyloid-beta.
- Have a centrally read MRI that does not meet study entry criteria.
- Have contraindication to MRI or PET scans.
- Have any contraindication to lumbar puncture.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (72)
72 openTrialSphere Corp
Chandler, Arizona, United States
- Contact480-508-1038
- Hemant Pandey · Principal investigator
RecruitingHonorHealth Research Institute
Scottsdale, Arizona, United States
- Todd Levine · Principal investigator
RecruitingProfound Research LLC
Carlsbad, California, United States
- Contact760-631-3000
- Benjamin Frishberg · Principal investigator
RecruitingIrvine Clinical Research
Irvine, California, United States
- Contact949-753-1663
- Elly Lee · Principal investigator
RecruitingUCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
- Stephanie Lessig · Principal investigator
Not yet recruitingStanford Neuroscience Health Center
Palo Alto, California, United States
- Contact818-398-9855
- Irina Skylar-Scott · Principal investigator
RecruitingCenExel Rocky Mountain Clinical Research
Englewood, Colorado, United States
- Meagen Salinas · Principal investigator
RecruitingKi Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
- Contact203-914-1903
- Peter McAllister · Principal investigator
RecruitingJEM Research Institute
Atlantis, Florida, United States
- Contact561-968-2933
- Linda Pao · Principal investigator
RecruitingVIN - Aventura
Aventura, Florida, United States
- Contact305-933-5993
- Jonathan Cross · Principal investigator
RecruitingBrain Matters Research
Delray Beach, Florida, United States
- Contact561-374-8461
- Paayal Patel · Principal investigator
RecruitingNeuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
- Contact239-939-7777
- John Huffaker · Principal investigator
RecruitingNorman Fixel Institute for Neurological Diseases (FIND)
Gainesville, Florida, United States
- Bhavana Patel · Principal investigator
Not yet recruitingMayo Clinic in Florida
Jacksonville, Florida, United States
- Neill Graff-Radford · Principal investigator
Not yet recruitingK2 Medical Research ORLANDO
Maitland, Florida, United States
- Contact407-500-5252
- Sheila Baez-Torres · Principal investigator
RecruitingBRP-Kendal Lakes
Miami, Florida, United States
- Jose Gonzalez · Principal investigator
RecruitingRenstar Medical Research
Ocala, Florida, United States
- Contact352-629-5800
- Anette Nieves · Principal investigator
RecruitingCharter Research - Orlando
Orlando, Florida, United States
- Contact407-337-1000
- Diana Balsalobre · Principal investigator
RecruitingAxiom Brain Health LLC
Tampa, Florida, United States
- Contact813-353-9613
- Susan Steen · Principal investigator
RecruitingPalm Beach Neurology
West Palm Beach, Florida, United States
- Contact561-845-0500
- Paul Winner · Principal investigator
RecruitingConquest Research
Winter Park, Florida, United States
- Contact407-916-0060
- Malisa Agard · Principal investigator
RecruitingIndiana University Health Neuroscience Center
Indianapolis, Indiana, United States
- Contact317-963-7402
- Jared Brosch · Principal investigator
RecruitingThe University of Kansas - Clinical Research Center
Fairway, Kansas, United States
- Contact913-574-0976
- Ryan Townley · Principal investigator
Not yet recruitingMassachusetts General Hospital - Charlestown
Charlestown, Massachusetts, United States
- Anna Goodheart · Principal investigator
Not yet recruitingK2 Medical Research - Foxborough
Foxborough, Massachusetts, United States
- Contact401-435-8950
- John Stoukides · Principal investigator
RecruitingNeurology Center of New England
Foxborough, Massachusetts, United States
- Contact781-551-5812
- Salvatore Napoli · Principal investigator
RecruitingHeadlands Eastern MA LLC
Plymouth, Massachusetts, United States
- Contact978-831-8041
- Kinan Hreib · Principal investigator
RecruitingQUEST Research Institute
Farmington Hills, Michigan, United States
- Contact248-957-8940
- Aaron Ellenbogen · Principal investigator
RecruitingStruthers Parkinson's Center
Golden Valley, Minnesota, United States
- Sotirios Parashos · Principal investigator
RecruitingMayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
- Jonathan Graff-Radford · Principal investigator
Not yet recruitingCitizens Memorial Hospital District
Bolivar, Missouri, United States
- Contact417-328-7781
- Curtis Schreiber · Principal investigator
RecruitingSummit Headlands
Portland, Oregon, United States
- Contact503-279-8252
- Scott Losk · Principal investigator
RecruitingOregon Health and Science University
Portland, Oregon, United States
- Aimee Pierce · Principal investigator
RecruitingPennsylvania Hospital
Philadelphia, Pennsylvania, United States
- Rebecca Williamson · Principal investigator
RecruitingGadolin Research
Beaumont, Texas, United States
- Contact409-331-6040
- Kandasami Senthilkumar · Principal investigator
RecruitingKerwin Medical Center
Dallas, Texas, United States
- Alka Khera · Principal investigator
RecruitingHouston Methodist Hospital
Houston, Texas, United States
- Juan Toledo Atucha · Principal investigator
RecruitingThe University of Texas Health Science Center at Houston
Houston, Texas, United States
- Contact713-486-0536
- David Hunter · Principal investigator
RecruitingCentral Texas Neurology Consultants
Round Rock, Texas, United States
- Contact512-218-1222
- Elizabeth Peckham · Principal investigator
RecruitingThe University of Texas Health Science Center
San Antonio, Texas, United States
- Sudha Seshadri · Principal investigator
RecruitingRe:Cognition Health
Fairfax, Virginia, United States
- Contact703-520-9703
- Raymond Turner · Principal investigator
RecruitingEvergreenHealth
Kirkland, Washington, United States
- Contact425-899-5385
- Pinky Agarwal · Principal investigator
Recruiting
30 sites outside the US
- Recruiting
- Recruiting
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Japan
- Contact81120023812
- Kenichi Shimada · Principal investigator
RecruitingInage Neurology and Memory Clinic
Inage, Japan
- Contact81120023812
- Yasumasa Yoshiyama · Principal investigator
RecruitingNippon Medical School Musashi Kosugi Hospital
Kawasaki, Japan
- Contact81120023812
- Kentaro Suzuki · Principal investigator
Not yet recruitingSt. Marianna University Hospital
Kawasaki, Japan
- Contact81120023812
- Koji Kasanuki · Principal investigator
Not yet recruiting- Recruiting
Juntendo Tokyo Koto Geriatric Medical Center
Kōtoku, Japan
- Contact81120023812
- Kenya Nishioka · Principal investigator
Not yet recruiting- Recruiting
- Recruiting
- Not yet recruiting
National Center for Geriatrics and Gerontology
Ōbu, Japan
- Contact81120023812
- Kazunori Imai · Principal investigator
Recruiting- Not yet recruiting
Tokyo Metropolitan Institute for Geriatrics and Gerontology
tabashi City, Japan
- Contact81120023812
- Atsushi Iwata · Principal investigator
Not yet recruiting- Recruiting
- Recruiting
Yokohama Minami Kyosai Hospital
Yokohama, Japan
- Contact81120023812
- Shigeru Koyano · Principal investigator
Recruiting- Not yet recruiting
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, South Korea
- Contact82-2-2019-3320
- Hanna Cho · Principal investigator
Not yet recruitingInha University Hospital
Incheon, South Korea
- Seong Hye Choi · Principal investigator
Not yet recruitingGachon University Gil Medical Center
Namdong-gu, South Korea
- Kee Hyung Park · Principal investigator
Not yet recruitingHanyang University Seoul Hospital
Seoul, South Korea
- Contact82-2-2290-8374
- Hee-Jin Kim · Principal investigator
Not yet recruitingKonkuk University Medical Center
Seoul, South Korea
- Seol-Heui Han · Principal investigator
Not yet recruitingEwha Womans University Mokdong Hospital
Seoul, South Korea
- Geon Ha Kim · Principal investigator
Not yet recruitingTaipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
- Contact02224900888819
- Chaur-Jong Hu · Principal investigator
Not yet recruitingNew Taipei Municipal TuCheng Hospital
New Taipei City, Taiwan
- Contact03-3281200
- Jung Lung Hsu · Principal investigator
Not yet recruitingNational Cheng Kung University Hospital
Tainan, Taiwan
- Contact886 972401434
- MingChyi Pai · Principal investigator
Not yet recruitingNational Taiwan University Hospital
Taipei, Taiwan
- Cheng-Hsuan Li · Principal investigator
Not yet recruitingTaipei Veterans General Hospital
Taipei, Taiwan
- Contact886228757578
- Jong-Ling Fuh · Principal investigator
Not yet recruitingChang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan
- WEI-MIN HO · Principal investigator
Not yet recruiting
Study team
Sponsor
Eli Lilly and Company
Study ID 27790
Study director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.