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

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

  • Cognitive Dysfunction
  • Lewy Body Disease
  • Synucleinopathies
  • Amyloid

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

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

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

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

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

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

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

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

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

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