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Phase 2Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

Where this study is enrolling (30)

  • HonorHealth Research Institute

    Scottsdale, Arizona

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  • TrialSphere Corp

    Chandler, Arizona

    I'm interested

  • Profound Research LLC

    Carlsbad, California

    Call 760-631-3000

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  • Irvine Clinical Research

    Irvine, California

    Call 949-753-1663

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  • Stanford Neuroscience Health Center

    Palo Alto, California

    Call 818-398-9855

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Show all 30 locations

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

    Stamford, Connecticut

    Call 203-914-1903

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  • JEM Research Institute

    Atlantis, Florida

    Call 561-968-2933

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  • Palm Beach Neurology

    West Palm Beach, Florida

    Call 561-845-0500

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  • K2 Medical Research ORLANDO

    Maitland, Florida

    Call 407-500-5252

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  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida

    Call 239-939-7777

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  • Brain Matters Research

    Delray Beach, Florida

    Call 561-374-8461

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  • VIN - Aventura

    Aventura, Florida

    Call 305-933-5993

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  • Charter Research - Orlando

    Orlando, Florida

    Call 407-337-1000

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  • Conquest Research

    Winter Park, Florida

    Call 407-916-0060

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  • Axiom Brain Health LLC

    Tampa, Florida

    Call 813-353-9613

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  • Renstar Medical Research

    Ocala, Florida

    Call 352-629-5800

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  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana

    Call 317-963-7402

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  • The University of Kansas - Clinical Research Center

    Fairway, Kansas

    Call 913-574-0976

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  • Headlands Eastern MA LLC

    Plymouth, Massachusetts

    Call 978-831-8041

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  • Neurology Center of New England

    Foxborough, Massachusetts

    Call 781-551-5812

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  • K2 Medical Research - Foxborough

    Foxborough, Massachusetts

    Call 401-435-8950

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  • QUEST Research Institute

    Farmington Hills, Michigan

    Call 248-957-8940

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  • Citizens Memorial Hospital District

    Bolivar, Missouri

    Call 417-328-7781

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  • Summit Headlands

    Portland, Oregon

    Call 503-279-8252

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  • Central Texas Neurology Consultants

    Round Rock, Texas

    Call 512-218-1222

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  • Houston Methodist Hospital

    Houston, Texas

    Call 713.790.3311

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  • Gadolin Research

    Beaumont, Texas

    Call 409-331-6040

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  • The University of Texas Health Science Center at Houston

    Houston, Texas

    Call 713-486-0536

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  • Re:Cognition Health

    Fairfax, Virginia

    Call 703-520-9703

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  • EvergreenHealth

    Kirkland, Washington

    Call 425-899-5385

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.