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

RecruitingPhase 3Ages 55 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Donanemab
  • Placebo
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Where

59 sites
Banner Alzheimer's Institute
Phoenix, United States
Care Access - Huntington Beach
Huntington Beach, United States
Irvine Clinical Research
Irvine, United States
Healthy Brain Clinic
Long Beach, United States
Artemis Institute for Clinical Research
Riverside, United States
Clinical Trials Research
Sacramento, United States
Artemis Institute for Clinical Research
San Diego, United States
Syrentis Clinical Research
Santa Ana, United States

โ€ฆand 51 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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