A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
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
2 other identifiers
interventional
350
4 countries
72
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedStudy Start
First participant enrolled
May 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
July 17, 2026
July 1, 2026
2.2 years
May 11, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Baseline through Week 52
Secondary Outcomes (9)
Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)
Baseline through Week 52
Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)
Baseline through Week 52
Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Baseline through Week 52
Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)
Baseline through Week 52
Change from Baseline in Brain Amyloid Plaque Levels
Baseline through Week 52
- +4 more secondary outcomes
Study Arms (2)
Donanemab (LY3002813)
EXPERIMENTALDonanemab (LY3002813) administered as an intravenous (IV) infusion
Placebo
PLACEBO COMPARATORPlacebo administered IV
Interventions
Eligibility Criteria
You 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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
TrialSphere Corp
Chandler, Arizona, 85286, United States
HonorHealth Research Institute
Scottsdale, Arizona, 85251, United States
Profound Research LLC
Carlsbad, California, 92011, United States
Irvine Clinical Research
Irvine, California, 92614, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037, United States
Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
VIN - Aventura
Aventura, Florida, 33180, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Norman Fixel Institute for Neurological Diseases (FIND)
Gainesville, Florida, 32608, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
K2 Medical Research ORLANDO
Maitland, Florida, 32751, United States
BRP-Kendal Lakes
Miami, Florida, 33175, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Charter Research - Orlando
Orlando, Florida, 32803, United States
Axiom Brain Health LLC
Tampa, Florida, 33609, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Conquest Research
Winter Park, Florida, 32789, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205, United States
Massachusetts General Hospital - Charlestown
Charlestown, Massachusetts, 02129, United States
K2 Medical Research - Foxborough
Foxborough, Massachusetts, 02035, United States
Neurology Center of New England
Foxborough, Massachusetts, 02035, United States
Headlands Eastern MA LLC
Plymouth, Massachusetts, 02360, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613, United States
Summit Headlands
Portland, Oregon, 97210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Kerwin Medical Center
Dallas, Texas, 75231, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681, United States
The University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
EvergreenHealth
Kirkland, Washington, 98034, United States
Memory Clinic Ochanomizu
Bunkyō City, 113-0034, Japan
Shonan Keiiku Hospital
Fujisawa, 252-0816, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, 670-8560, Japan
Inage Neurology and Memory Clinic
Inage, 263-0043, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, 211-8533, Japan
St. Marianna University Hospital
Kawasaki, 216-8511, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Kōtoku, 136-0075, Japan
Katayama Medical Clinic
Kurashiki, 710-0813, Japan
Nagoya Ekisaikai Hospital
Nagoya, 454-8502, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
National Center for Geriatrics and Gerontology
Ōbu, 474-8511, Japan
The University of Osaka Hospital
Suita, 565-0871, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
tabashi City, 173-0015, Japan
Tachikawa Hospital
Tachikawa, 190-8531, Japan
Memory Clinic Toride
Toride, 302-0004, Japan
Yokohama Minami Kyosai Hospital
Yokohama, 236-0037, Japan
Oita University Hospital
Yufu, 879-5593, Japan
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, 236, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 15, 2026
Study Start
May 20, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or 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 should be approved by an independent review panel and researchers should 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.