Recruiting
Phase 2

Donanemab

Sponsor:

Eli Lilly and Company

Code:

NCT07589595

Conditions

Cognitive Dysfunction

Lewy Body Disease

Synucleinopathies

Amyloid

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Donanemab

Placebo

Study Details

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.

Conditions

Cognitive Dysfunction

Lewy Body Disease

Synucleinopathies

Amyloid

Study ID

NCT07589595

Start date

May 20, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Donanemab (LY3002813)

Donanemab (LY3002813) administered as an intravenous (IV) infusion

placebo comparator: Placebo

Placebo administered IV

Interventions

Donanemab

Donanemab administered IV

Placebo

Placebo administered IV

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

TrialSphere Corp

Recruiting

Chandler, Arizona, United States, 85286

Contacts

480-508-1038

Principal Investigator:

Hemant Pandey

Profound Research LLC

Recruiting

Carlsbad, California, United States, 92011

Contacts

760-631-3000

Principal Investigator:

Benjamin Frishberg

Irvine Clinical Research

Recruiting

Irvine, California, United States, 92614

Contacts

949-753-1663

Principal Investigator:

Edward Zamrini

JEM Research Institute

Recruiting

Atlantis, Florida, United States, 33462

Contacts

561-968-2933

Principal Investigator:

Linda Pao

VIN - Aventura

Recruiting

Aventura, Florida, United States, 33180

Contacts

305-933-5993

Principal Investigator:

Jonathan Cross

Brain Matters Research

Recruiting

Delray Beach, Florida, United States, 33445

Contacts

561-374-8461

Principal Investigator:

Paayal Patel

Neuropsychiatric Research Center of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

239-939-7777

Principal Investigator:

John Huffaker

K2 Medical Research ORLANDO

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Sheila Baez-Torres

BRP-Kendal Lakes

Recruiting

Miami, Florida, United States, 33175

Principal Investigator:

Jose Gonzalez

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34471

Contacts

352-629-5800

Principal Investigator:

Anette Nieves

Charter Research - Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

407-337-1000

Principal Investigator:

Diana Balsalobre

Axiom Brain Health LLC

Recruiting

Tampa, Florida, United States, 33609

Contacts

813-353-9613

Principal Investigator:

Susan Steen

Palm Beach Neurology

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

561-845-0500

Principal Investigator:

Paul Winner

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

407-916-0060

Principal Investigator:

Malisa Agard

Indiana University Health Neuroscience Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

317-963-7402

Principal Investigator:

Jared Brosch

K2 Medical Research - Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

401-435-8950

Principal Investigator:

john stoukides

Neurology Center of New England

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

781-551-5812

Principal Investigator:

Salvatore Napoli

Headlands Eastern MA LLC

Recruiting

Plymouth, Massachusetts, United States, 02360

Contacts

978-831-8041

Principal Investigator:

Kinan Hreib

QUEST Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

248-957-8940

Principal Investigator:

Aaron Ellenbogen

Citizens Memorial Hospital District

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

417-328-7781

Principal Investigator:

Curtis Schreiber

Summit Headlands

Recruiting

Portland, Oregon, United States, 97210

Contacts

503-279-8252

Principal Investigator:

Scott Losk

Gadolin Research

Recruiting

Beaumont, Texas, United States, 77702

Contacts

409-331-6040

Principal Investigator:

Kandasami Senthilkumar

Kerwin Medical Center

Recruiting

Dallas, Texas, United States, 75231

Principal Investigator:

Alka Khera

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

713-486-0536

Principal Investigator:

David Hunter

Central Texas Neurology Consultants

Recruiting

Round Rock, Texas, United States, 78681

Contacts

512-218-1222

Principal Investigator:

Elizabeth Peckham

Re:Cognition Health

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

703-520-9703

Principal Investigator:

Raymond Turner

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Mild Cognitive Impairment
  • Mild Dementia
  • Brain Diseases
  • Nervous System Diseases
  • Neurodegenerative Diseases
  • Neurocognitive Disorders
  • Cognition Disorders
  • Alzheimer Disease
  • Cognitive Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-25.