臨床研究等提出・公開システム

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM (I5T-MC-AACY)

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). (I5T-MC-AACY)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

July. 15, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Alzheimer Disease
Dementia
Plaque, Amyloid

DRUG: Donanemab
Administered IV
DRUG: Placebo
Administered IV

(Study Arms)
Experimental: Donanemab
Donanemab administered intravenously (IV)
Interventions:
Drug: Donanemab
Placebo Comparator: Placebo
Placebo IV
Interventions:
Drug: Placebo

Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) [Time Frame: Baseline through Week 130]

+81-42-625-5216

June. 23, 2026

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States/Puerto Rico