A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
Recruiting
Phase 3Interventional Study
Alzheimer DiseaseDementiaPlaque, Amyloid
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for people who have previously participated in a related study and who want to see if they benefit from yearly doses of donanemab. Participants will attend up to 6 visits during the study, which lasts up to 2.5 years.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed study AACM Addendum 7.
I have a reliable study partner who knows my daily activities.
I am assigned female at birth and not able to become pregnant, or I am assigned male at birth.
You may not be able to join if
I have a serious illness that may affect my participation.
I have claustrophobia or incompatible metal implants that prevent an MRI.
I have any brain condition or injury that may be unsafe.
I cannot have PET scans due to medical reasons.
I have received amyloid-targeting therapy other than donanemab.
I have participated in another clinical trial in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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, …
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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