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Purpose

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

Eligibility

Eligible Ages
Between 55 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Donanemab (LY3002813) 		Donanemab (LY3002813) administered as an intravenous (IV) infusion
  • Drug: Donanemab
    Donanemab administered IV
    Other names:
    • LY3002813
Placebo Comparator
Placebo 		Placebo administered IV
  • Drug: Placebo
    Placebo administered IV

Recruiting Locations

TrialSphere Corp
Chandler, Arizona 85286
Contact:
480-508-1038

Profound Research LLC
Carlsbad, California 92011
Contact:
760-631-3000

Irvine Clinical Research
Irvine, California 92614
Contact:
949-753-1663

JEM Research Institute
Atlantis, Florida 33462
Contact:
561-968-2933

VIN - Aventura
Aventura, Florida 33180
Contact:
305-933-5993

Brain Matters Research
Delray Beach, Florida 33445
Contact:
561-374-8461

Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
Contact:
239-939-7777

K2 Medical Research ORLANDO
Maitland, Florida 32751
Contact:
407-500-5252

BRP-Kendal Lakes
Miami, Florida 33175

Renstar Medical Research
Ocala, Florida 34471
Contact:
352-629-5800

Charter Research - Orlando
Orlando, Florida 32803
Contact:
407-337-1000

Axiom Brain Health LLC
Tampa, Florida 33609
Contact:
813-353-9613

Palm Beach Neurology
West Palm Beach, Florida 33407
Contact:
561-845-0500

Conquest Research
Winter Park, Florida 32789
Contact:
407-916-0060

Indiana University Health Neuroscience Center
Indianapolis, Indiana 46202
Contact:
317-963-7402

K2 Medical Research - Foxborough
Foxborough, Massachusetts 02035
Contact:
401-435-8950

Neurology Center of New England
Foxborough, Massachusetts 02035
Contact:
781-551-5812

Headlands Eastern MA LLC
Plymouth, Massachusetts 02360
Contact:
978-831-8041

QUEST Research Institute
Farmington Hills, Michigan 48334
Contact:
248-957-8940

Citizens Memorial Hospital District
Bolivar, Missouri 65613
Contact:
417-328-7781

Summit Headlands
Portland, Oregon 97210
Contact:
503-279-8252

Gadolin Research
Beaumont, Texas 77702
Contact:
409-331-6040

Kerwin Medical Center
Dallas, Texas 75231

The University of Texas Health Science Center at Houston
Houston, Texas 77054
Contact:
713-486-0536

Central Texas Neurology Consultants
Round Rock, Texas 78681
Contact:
512-218-1222

Re:Cognition Health
Fairfax, Virginia 22031
Contact:
703-520-9703

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.