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RecruitingPhase 2

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

Eli Lilly and Company · NCT07589595

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
350
US sites recruiting
30
Study start
May 20, 2026
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Donanemab; Placebo

Conditions: Cognitive Dysfunction; Lewy Body Disease; Synucleinopathies; Amyloid

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • TrialSphere Corp

    Chandler, AZ 85286

    Site contact: 480-508-1038

  • Profound Research LLC

    Carlsbad, CA 92011

    Site contact: 760-631-3000

  • Irvine Clinical Research

    Irvine, CA 92614

    Site contact: 949-753-1663

  • Stanford Neuroscience Health Center

    Palo Alto, CA 94304

    Site contact: 818-398-9855

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    Stamford, CT 06905

    Site contact: 203-914-1903

  • JEM Research Institute

    Atlantis, FL 33462

    Site contact: 561-968-2933

  • VIN - Aventura

    Aventura, FL 33180

    Site contact: 305-933-5993

  • Brain Matters Research

    Delray Beach, FL 33445

    Site contact: 561-374-8461

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, FL 33912

    Site contact: 239-939-7777

  • K2 Medical Research ORLANDO

    Maitland, FL 32751

    Site contact: 407-500-5252

  • BRP-Kendal Lakes

    Miami, FL 33175

    Site contact: Jose Gonzalez

  • Renstar Medical Research

    Ocala, FL 34471

    Site contact: 352-629-5800

  • Charter Research - Orlando

    Orlando, FL 32803

    Site contact: 407-337-1000

  • Axiom Brain Health LLC

    Tampa, FL 33609

    Site contact: 813-353-9613

  • Palm Beach Neurology

    West Palm Beach, FL 33407

    Site contact: 561-845-0500

  • Conquest Research

    Winter Park, FL 32789

    Site contact: 407-916-0060

  • Indiana University Health Neuroscience Center

    Indianapolis, IN 46202

    Site contact: 317-963-7402

  • K2 Medical Research - Foxborough

    Foxborough, MA 02035

    Site contact: 401-435-8950

  • Neurology Center of New England

    Foxborough, MA 02035

    Site contact: 781-551-5812

  • Headlands Eastern MA LLC

    Plymouth, MA 02360

    Site contact: 978-831-8041

  • QUEST Research Institute

    Farmington Hills, MI 48334

    Site contact: 248-957-8940

  • Citizens Memorial Hospital District

    Bolivar, MO 65613

    Site contact: 417-328-7781

  • Summit Headlands

    Portland, OR 97210

    Site contact: 503-279-8252

  • Gadolin Research

    Beaumont, TX 77702

    Site contact: 409-331-6040

  • Kerwin Medical Center

    Dallas, TX 75231

    Site contact: Alka Khera

  • The University of Texas Health Science Center at Houston

    Houston, TX 77054

    Site contact: 713-486-0536

  • Central Texas Neurology Consultants

    Round Rock, TX 78681

    Site contact: 512-218-1222

  • The University of Texas Health Science Center

    San Antonio, TX 78229

    Site contact: Sudha Seshadri

  • Re:Cognition Health

    Fairfax, VA 22031

    Site contact: 703-520-9703

  • EvergreenHealth

    Kirkland, WA 98034

    Site contact: 425-899-5385

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Donanemab (LY3002813) in Participants With Early… (NCT07589595) | Bored Studies