Yearly donanemab doses for people with Alzheimer disease who finished an earlier donanemab study
Tests yearly donanemab doses in people who completed an earlier donanemab study.
Plain-language title generated from the registry record
Registry title: A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
Key facts
- Where
- Chūōku, Hachiōji, Ōbu, Shinjuku, Shinjyuku, and tabashi City, JapanSee the 6 sites
- Phase
- Phase 3
Where in Japan
- Tokyo-Eki Center-building ClinicChūōku, JapanTaking people
- P-One ClinicHachiōji, JapanTaking people
- National Center for Geriatrics and GerontologyŌbu, JapanNot yet recruiting
- Samoncho ClinicShinjuku, JapanNot yet recruiting
- Yotsuya Internal Medicine ClinicShinjyuku, JapanTaking people
- Tokyo Metropolitan Institute for Geriatrics and Gerontologytabashi City, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07602582
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM
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.
Inclusion: 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: 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 had history of amyloid-targeting therapy treatment outside donanemab trials; 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 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.