A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

May 11, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Japan
      • Bunkyō City, Japan, 113-0034
        • Memory Clinic Ochanomizu
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takashi Asada
      • Fujisawa, Japan, 252-0816
        • Shonan Keiiku Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasuo Terayama
      • Himeji, Japan, 670-8560
        • Hyogo Prefectural Harima-Himeji General Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenichi Shimada
      • Inage, Japan, 263-0043
        • Inage Neurology and Memory Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasumasa Yoshiyama
      • Kawasaki, Japan, 216-8511
        • St. Marianna University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Kasanuki
      • Kawasaki, Japan, 211-8533
        • Nippon Medical School Musashi Kosugi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kentaro Suzuki
      • Kobe, Japan, 650-0017
        • Kobe University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hisatomo Kowa
      • Kurashiki, Japan, 710-0813
        • Katayama Medical Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sadao Katayama
      • Kōtoku, Japan, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenya Nishioka
      • Nagoya, Japan, 466-8560
        • Nagoya University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahisa Katsuno
      • Tachikawa, Japan, 190-8531
        • Tachikawa Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hidenori Hattori
      • Toride, Japan, 302-0004
        • Memory Clinic Toride
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Youshun Boku
      • Yokohama, Japan, 236-0037
        • Yokohama Minami Kyosai Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shigeru Koyano
      • Yufu, Japan, 879-5593
        • Oita University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Noriyuki Kimura
      • tabashi City, Japan, 173-0015
        • Tokyo Metropolitan Institute for Geriatrics and Gerontology
        • Principal Investigator:
          • Atsushi Iwata
        • Contact:
          • Phone Number: 81120023812
      • Ōbu, Japan, 474-8511
        • National Center for Geriatrics and Gerontology
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazunori Imai
  • South Korea
      • Gangnam-gu, South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
        • Contact:
          • Phone Number: +82-10-3000-4975
        • Principal Investigator:
          • Hanna Cho
      • Incheon, South Korea, 22332
        • Inha University Hospital
        • Principal Investigator:
          • Seong Hye Choi
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Byoung Seok Ye
        • Contact:
          • Phone Number: 82-10-2505-9280
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center
        • Principal Investigator:
          • Seol-Heui Han
      • Seoul, South Korea, 07985
        • Ewha Womans University Mokdong Hospital
        • Principal Investigator:
          • Geon Ha Kim
      • Seoul, South Korea, 04763
        • Hanyang University Seoul Hospital
        • Principal Investigator:
          • Hee-Jin Kim
        • Contact:
          • Phone Number: 82-2-2290-8374
  • Taiwan
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital
        • Principal Investigator:
          • Chaur-Jong Hu
        • Contact:
          • Phone Number: 02224900888819
      • New Taipei City, Taiwan, 236
        • New Taipei Municipal TuCheng Hospital
        • Principal Investigator:
          • Jung Lung Hsu
        • Contact:
          • Phone Number: 03-3281200
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • MingChyi Pai
        • Contact:
          • Phone Number: 886 972401434
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
        • Principal Investigator:
          • Cheng-Hsuan Li
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
        • Contact:
          • Phone Number: 886228757578
        • Principal Investigator:
          • Jong-Ling Fuh
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Yi-Chun Chen
        • Contact:
          • Phone Number: +886-3-3281200 ext 8347
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • TrialSphere Corp
        • Principal Investigator:
          • Hemant Pandey
        • Contact:
          • Phone Number: 480-508-1038
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
        • Principal Investigator:
          • Todd Levine
    • California
      • Carlsbad, California, United States, 92011
        • Profound Research LLC
        • Contact:
          • Phone Number: 760-631-3000
        • Principal Investigator:
          • Benjamin Frishberg
      • Irvine, California, United States, 92614
        • Irvine Clinical Research
        • Contact:
          • Phone Number: 949-753-1663
        • Principal Investigator:
          • Edward Zamrini
      • La Jolla, California, United States, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
        • Principal Investigator:
          • Stephanie Lessig
      • Palo Alto, California, United States, 94304
        • Stanford Neuroscience Health Center
        • Principal Investigator:
          • Irina Skylar-Scott
        • Contact:
          • Phone Number: 818-398-9855
    • Colorado
      • Englewood, Colorado, United States, 80113
        • CenExel Rocky Mountain Clinical Research
        • Principal Investigator:
          • Meagen Salinas
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Ki Health Partners, LLc, dba New England Institute for Clinical Research
        • Contact:
          • Phone Number: 203-914-1903
        • Principal Investigator:
          • Peter McAllister
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
        • Contact:
          • Phone Number: 561-968-2933
        • Principal Investigator:
          • Linda Pao
      • Aventura, Florida, United States, 33180
        • VIN - Aventura
        • Contact:
          • Phone Number: 305-933-5993
        • Principal Investigator:
          • Jonathan Cross
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
        • Contact:
          • Phone Number: 561-374-8461
        • Principal Investigator:
          • Paayal Patel
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
        • Contact:
          • Phone Number: 239-939-7777
        • Principal Investigator:
          • John Huffaker
      • Gainesville, Florida, United States, 32608
        • Norman Fixel Institute for Neurological Diseases (FIND)
        • Principal Investigator:
          • Bhavana Patel
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Neill Graff-Radford
      • Maitland, Florida, United States, 32751
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Sheila Baez-Torres
      • Miami, Florida, United States, 33175
        • BRP-Kendal Lakes
        • Principal Investigator:
          • Jose Gonzalez
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
        • Principal Investigator:
          • Anette Nieves
        • Contact:
          • Phone Number: 352-629-5800
      • Orlando, Florida, United States, 32803
        • Charter Research - Orlando
        • Contact:
          • Phone Number: 407-337-1000
        • Principal Investigator:
          • Diana Balsalobre
      • Tampa, Florida, United States, 33609
        • Axiom Brain Health LLC
        • Contact:
          • Phone Number: 813-353-9613
        • Principal Investigator:
          • Susan Steen
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology
        • Contact:
          • Phone Number: 561-845-0500
        • Principal Investigator:
          • Paul Winner
      • Winter Park, Florida, United States, 32789
        • Conquest Research
        • Contact:
          • Phone Number: 407-916-0060
        • Principal Investigator:
          • Malisa Agard
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Neuroscience Center
        • Contact:
          • Phone Number: 317-963-7402
        • Principal Investigator:
          • Jared Brosch
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas - Clinical Research Center
        • Principal Investigator:
          • Ryan Townley
        • Contact:
          • Phone Number: 913-574-0976
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital - Charlestown
        • Principal Investigator:
          • Anna Goodheart
      • Foxborough, Massachusetts, United States, 02035
        • Neurology Center of New England
        • Principal Investigator:
          • Salvatore Napoli
        • Contact:
          • Phone Number: 781-551-5812
      • Plymouth, Massachusetts, United States, 02360
        • Headlands Eastern MA LLC
        • Contact:
          • Phone Number: 978-831-8041
        • Principal Investigator:
          • Kinan Hreib
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
        • Contact:
          • Phone Number: 248-957-8940
        • Principal Investigator:
          • Aaron Ellenbogen
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Struthers Parkinson's Center
        • Principal Investigator:
          • Sotirios Parashos
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester, Minnesota
        • Principal Investigator:
          • Jonathan Graff-Radford
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Citizens Memorial Hospital District
        • Contact:
          • Phone Number: 417-328-7781
        • Principal Investigator:
          • Curtis Schreiber
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
        • Principal Investigator:
          • Aimee Pierce
      • Portland, Oregon, United States, 97210
        • Summit Headlands
        • Principal Investigator:
          • Scott Losk
        • Contact:
          • Phone Number: 503-279-8252
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
        • Principal Investigator:
          • Rebecca Williamson
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • K2 Medical Research - East Providence
        • Contact:
          • Phone Number: 401-435-8950
        • Principal Investigator:
          • john stoukides
    • Texas
      • Beaumont, Texas, United States, 77702
        • Gadolin Research
        • Contact:
          • Phone Number: 409-331-6040
        • Principal Investigator:
          • Kandasami Senthilkumar
      • Dallas, Texas, United States, 75231
        • Kerwin Medical Center
        • Principal Investigator:
          • Alka Khera
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
        • Principal Investigator:
          • Juan Toledo Atucha
      • Houston, Texas, United States, 77054
        • The University of Texas Health Science Center at Houston
        • Contact:
          • Phone Number: 713-486-0536
        • Principal Investigator:
          • David Hunter
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultants
        • Contact:
          • Phone Number: 512-218-1222
        • Principal Investigator:
          • Elizabeth Peckham
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center
        • Principal Investigator:
          • Sudha Seshadri
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Re:Cognition Health
        • Principal Investigator:
          • Raymond Turner
        • Contact:
          • Phone Number: 703-520-9703
    • Washington
      • Kirkland, Washington, United States, 98034
        • EvergreenHealth
        • Contact:
          • Phone Number: 425-899-5385
        • Principal Investigator:
          • Pinky Agarwal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered IV
Drug: Placebo
Placebo administered IV
Experimental: Donanemab (LY3002813)
Donanemab (LY3002813) administered as an intravenous (IV) infusion
Drug: Donanemab
Donanemab administered IV
Other Names:
  • LY3002813

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time Frame: Baseline through Week 52
Baseline through Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)
Time Frame: Baseline through Week 52
Baseline through Week 52
Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)
Time Frame: Baseline through Week 52
Baseline through Week 52
Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Time Frame: Baseline through Week 52
Baseline through Week 52
Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)
Time Frame: Baseline through Week 52
Baseline through Week 52
Change from Baseline in Brain Amyloid Plaque Levels
Time Frame: Baseline through Week 52
Baseline through Week 52
Trough Concentration at Steady State
Time Frame: Baseline through Week 52
Baseline through Week 52
Maximum Concentration at Steady State
Time Frame: Baseline through Week 52
Baseline through Week 52
Antidrug Antibodies (ADA) Against Donanemab
Time Frame: Baseline through Week 52
Baseline through Week 52
Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants
Time Frame: Baseline through Week 52
Baseline through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27790
  • I5T-MC-AACV (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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