← Trials/Trial dossier/NCT07602582

RecruitingPhase 3

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

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

550

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID27890

Secondary IDI5T-MC-AACYEli Lilly and Company

NCT IDNCT07602582

Timeline

Milestones

Study first posted2026-05-22actual

Study start2026-05-22actual

Last update posted2026-07-07actual

Primary completion2029-09estimated (month precision)

Study completion2029-09estimated (month precision)

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Amyloid biomarkers

Tau biomarkers

Safety / tolerability / PK

Global cognition

2 endpoints

Primary/protocol endpoint

Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Time frame:Baseline through Week 130

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline as Measured by Cognitive Function Index (CFI)

Time frame:Baseline through Week 130

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.

Time frame:Baseline through Week 130

change from baseline, improvement

Tau biomarkers

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)

Time frame:Baseline through Week 130

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab

Time frame:Baseline, Week 52, Week 104

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.