Cognitive DysfunctionPhase 2NCT07589595
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
A Phase 2 study testing Donanemab in people with Cognitive Dysfunction and Lewy Body Disease, run by Eli Lilly and Company at 72 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies
- What is being tested?
- Donanemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 72 sitesin 4 countries
- Study dates
- 20 May 2026to Aug 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
72 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
72 sites in 4 countries
United States42 sites, 42 recruiting
- Recruiting
JEM Research Institute
Atlantis, Florida, 33462
561-968-2933
Linda Pao
- Recruiting
VIN - Aventura
Aventura, Florida, 33180
305-933-5993
Jonathan Cross
- Recruiting
Gadolin Research
Beaumont, Texas, 77702
409-331-6040
Kandasami Senthilkumar
- Recruiting
Citizens Memorial Hospital District
Bolivar, Missouri, 65613
417-328-7781
Curtis Schreiber
- Recruiting
Profound Research LLC
Carlsbad, California, 92011
760-631-3000
Benjamin Frishberg
- Recruiting
TrialSphere Corp
Chandler, Arizona, 85286
480-508-1038
Hemant Pandey
- Not yet recruiting
Massachusetts General Hospital - Charlestown
Charlestown, Massachusetts, 02129
Anna Goodheart
- Recruiting
Kerwin Medical Center
Dallas, Texas, 75231
Alka Khera
- Recruiting
Brain Matters Research
Delray Beach, Florida, 33445
561-374-8461
Paayal Patel
- Not yet recruiting
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113
Meagen Salinas
- Recruiting
Re:Cognition Health
Fairfax, Virginia, 22031
703-520-9703
Raymond Turner
- Not yet recruiting
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205
913-574-0976
Ryan Townley
- Recruiting
QUEST Research Institute
Farmington Hills, Michigan, 48334
248-957-8940
Aaron Ellenbogen
- Recruiting
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
239-939-7777
John Huffaker
- Recruiting
K2 Medical Research - Foxborough
Foxborough, Massachusetts, 02035
401-435-8950
john stoukides
- Recruiting
Neurology Center of New England
Foxborough, Massachusetts, 02035
781-551-5812
Salvatore Napoli
- Not yet recruiting
Norman Fixel Institute for Neurological Diseases (FIND)
Gainesville, Florida, 32608
Bhavana Patel
- Not yet recruiting
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Sotirios Parashos
- Not yet recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Juan Toledo Atucha
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
713-486-0536
David Hunter
- Recruiting
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
317-963-7402
Jared Brosch
- Recruiting
Irvine Clinical Research
Irvine, California, 92614
949-753-1663
Elly Lee
- Not yet recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Neill Graff-Radford
- Recruiting
EvergreenHealth
Kirkland, Washington, 98034
425-899-5385
Pinky Agarwal
- Not yet recruiting
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037
Stephanie Lessig
- Recruiting
K2 Medical Research ORLANDO
Maitland, Florida, 32751
407-500-5252
Sheila Baez-Torres
- Recruiting
BRP-Kendal Lakes
Miami, Florida, 33175
Jose Gonzalez
- Recruiting
Renstar Medical Research
Ocala, Florida, 34471
352-629-5800
Anette Nieves
- Recruiting
Charter Research - Orlando
Orlando, Florida, 32803
407-337-1000
Diana Balsalobre
- Recruiting
Stanford Neuroscience Health Center
Palo Alto, California, 94304
818-398-9855
Irina Skylar-Scott
- Not yet recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Rebecca Williamson
- Recruiting
Headlands Eastern MA LLC
Plymouth, Massachusetts, 02360
978-831-8041
Kinan Hreib
- Recruiting
Summit Headlands
Portland, Oregon, 97210
503-279-8252
Scott Losk
- Not yet recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Aimee Pierce
- Not yet recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Jonathan Graff-Radford
- Recruiting
Central Texas Neurology Consultants
Round Rock, Texas, 78681
512-218-1222
Elizabeth Peckham
- Recruiting
The University of Texas Health Science Center
San Antonio, Texas, 78229
Sudha Seshadri
- Not yet recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85251
Todd Levine
- Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
203-914-1903
Peter McAllister
- Recruiting
Axiom Brain Health LLC
Tampa, Florida, 33609
813-353-9613
Susan Steen
- Recruiting
Palm Beach Neurology
West Palm Beach, Florida, 33407
561-845-0500
Paul Winner
- Recruiting
Conquest Research
Winter Park, Florida, 32789
407-916-0060
Malisa Agard
Japan18 sites, 18 recruiting
- Recruiting
Memory Clinic Ochanomizu
Bunkyō City, 113-0034
81120023812
Takashi Asada
- Not yet recruiting
Shonan Keiiku Hospital
Fujisawa, 252-0816
81120023812
Yasuo Terayama
- Recruiting
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, 670-8560
81120023812
Kenichi Shimada
- Recruiting
Inage Neurology and Memory Clinic
Inage, 263-0043
81120023812
Yasumasa Yoshiyama
- Not yet recruiting
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, 211-8533
81120023812
Kentaro Suzuki
- Not yet recruiting
St. Marianna University Hospital
Kawasaki, 216-8511
81120023812
Koji Kasanuki
- Recruiting
Kobe University Hospital
Kobe, 650-0017
81120023812
Hisatomo Kowa
- Not yet recruiting
Juntendo Tokyo Koto Geriatric Medical Center
Kōtoku, 136-0075
81120023812
Kenya Nishioka
- Recruiting
Katayama Medical Clinic
Kurashiki, 710-0813
81120023812
Sadao Katayama
- Recruiting
Nagoya Ekisaikai Hospital
Nagoya, 454-8502
81120023812
Tomotsugu Kaga
- Not yet recruiting
Nagoya University Hospital
Nagoya, 466-8560
81120023812
Masahisa Katsuno
- Recruiting
National Center for Geriatrics and Gerontology
Ōbu, 474-8511
81120023812
Kazunori Imai
- Not yet recruiting
The University of Osaka Hospital
Suita, 565-0871
81120023812
Yuto Satake
- Not yet recruiting
Tokyo Metropolitan Institute for Geriatrics and Gerontology
tabashi City, 173-0015
81120023812
Atsushi Iwata
- Recruiting
Tachikawa Hospital
Tachikawa, 190-8531
81120023812
Hidenori Hattori
- Recruiting
Memory Clinic Toride
Toride, 302-0004
81120023812
Youshun Boku
- Not yet recruiting
Yokohama Minami Kyosai Hospital
Yokohama, 236-0037
81120023812
Shigeru Koyano
- Not yet recruiting
Oita University Hospital
Yufu, 879-5593
81120023812
Noriyuki Kimura
South Korea6 sites, 6 recruiting
- Not yet recruiting
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273
82-2-2019-3320
Hanna Cho
- Not yet recruiting
Inha University Hospital
Incheon, 22332
Seong Hye Choi
- Not yet recruiting
Gachon University Gil Medical Center
Namdong-gu, 21565
Kee Hyung Park
- Not yet recruiting
Hanyang University Seoul Hospital
Seoul, 04763
82-2-2290-8374
Hee-Jin Kim
- Not yet recruiting
Konkuk University Medical Center
Seoul, 05030
Seol-Heui Han
- Not yet recruiting
Ewha Womans University Mokdong Hospital
Seoul, 07985
Geon Ha Kim
Taiwan6 sites, 6 recruiting
- Not yet recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
02224900888819
Chaur-Jong Hu
- Not yet recruiting
New Taipei Municipal TuCheng Hospital
New Taipei City, 236
03-3281200
Jung Lung Hsu
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 704
886 972401434
MingChyi Pai
- Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
Cheng-Hsuan Li
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 11217
886228757578
Jong-Ling Fuh
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
WEI-MIN HO
About this study
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
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.
- Conditions
- Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid
- Being tested
- Donanemab, Placebo
- Keywords
- Mild Cognitive Impairment, Mild Dementia, Brain Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Cognition Disorders, Alzheimer Disease, Cognitive Dysfunction
- Medical subject headings
- Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Alzheimer Disease, Brain Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
Also called LY3002813
Donanemab administered IV
PlaceboDrug
Placebo administered IV
| Study group | Role | What they receive |
|---|---|---|
| Donanemab (LY3002813) | Experimental | Donanemab (LY3002813) administered as an intravenous (IV) infusion Receives: Drug: Donanemab |
| Placebo | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Measured: Baseline through Week 52
Secondary outcomes (9)
Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)
Measured: Baseline through Week 52
Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)
Measured: Baseline through Week 52
Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Measured: Baseline through Week 52
Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)
Measured: Baseline through Week 52
Change from Baseline in Brain Amyloid Plaque Levels
Measured: Baseline through Week 52
Trough Concentration at Steady State
Measured: Baseline through Week 52
Maximum Concentration at Steady State
Measured: Baseline through Week 52
Antidrug Antibodies (ADA) Against Donanemab
Measured: Baseline through Week 52
Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start20 May 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589595
- Sponsor's protocol ID
- 27790
- Other IDs
- I5T-MC-AACV
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.