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Recruiting Phase 3

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

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About this study

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.

Condition
Alzheimer Disease, Dementia, Plaque, Amyloid
Tested
Donanemab, Placebo
Sponsor
Eli Lilly and Company

Who can join

Age
55 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 55 years
  • Study condition: Alzheimer Disease, Dementia, Plaque, Amyloid
  • 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 7

  • 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.

Where

59 sites, 59 recruiting

VIN - Aventura

Aventura, Florida, United States

Recruiting

Gadolin Research

Beaumont, Texas, United States

Recruiting

Northwest Clinical Research Center

Bellevue, Washington, United States

Recruiting

Northwest Clinical Trials

Boise, Idaho, United States

Recruiting

Citizens Memorial Hospital District

Bolivar, Missouri, United States

Recruiting

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Recruiting

and 53 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.