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

NCT07602582

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Alzheimer Disease, Dementia, Plaque, Amyloid

Interventions: Donanemab, Placebo

Countries: United States, Japan, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 55 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (59)
  • Phoenix, Arizona, United States
  • Huntington Beach, California, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Riverside, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Santa Ana, California, United States
  • Santa Rosa, California, United States
  • Walnut Creek, California, United States
  • Aventura, Florida, United States
  • Bradenton, Florida, United States
  • Greenacres City, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Merritt Island, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Mt. Dora, Florida, United States
  • New Port Richey, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • Port Orange, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • The Villages, Florida, United States
  • Winter Park, Florida, United States
  • Gainesville, Georgia, United States
  • + 29 more on CT.gov