A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Purpose

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Conditions

  • Alzheimer Disease
  • Dementia
  • Plaque, Amyloid

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have completed study AACM Addendum 7. - Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. - Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth. - Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

  • Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study. - Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. - Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution. - Contraindication to florbetapir F 18 PET. - Have had history of amyloid-targeting therapy treatment outside donanemab trials. - Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Donanemab 		Donanemab administered intravenously (IV)
  • Drug: Donanemab
    Administered IV
Placebo Comparator
Placebo 		Placebo IV
  • Drug: Placebo
    Administered IV

Recruiting Locations

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

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