Active not recruitingPhase 3Results posted

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

1,175

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required (PET)•MMSE 20-28•MRI contraindications excluded

Primary endpoint

•Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

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 ID18648

Secondary ID2022-502268-18-00EU Trial Number

Secondary IDI5T-MC-AACQEli Lilly and Company

NCT IDNCT05738486

Secondary IDU1111-1285-9438UTN Number

Timeline

Milestones

Study first posted2023-02-22actual

Study start2023-02-28actual

Primary completion2024-05-16actual

Results first posted2025-11-14actual

Last update posted2026-06-18actual

Study completion2027-05estimated (month precision)

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.

•A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.

•Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology

Exclusion criteria

•Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.

•Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.

•A life expectancy of <24 months.

•Contraindication to MRI or PET scans

•Have had prior treatment with a passive anti-amyloid immunotherapy.

•Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

•non-metastatic basal- or squamous-cell skin cancer

•Stage 0 non-invasive carcinoma of the cervix

•Stage 0 non-invasive prostate cancer, or

•other cancers with low risk of recurrence or spread

Endpoints (16)

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

Other (unclassified)

Amyloid biomarkers

Safety / tolerability / PK

Amyloid biomarkers

6 endpoints

Primary/protocol endpoint

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

Time frame:24 Weeks

threshold achievement, improvement

Primary/registry result

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

Time frame:24 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
1400 mg Donanemab - Standard Regimenn=207 Participants	23.67	-
1400 mg Donanemab - Dose Skippingn=210 Participants	18.57	-
1400 mg Donanemab - Titrationn=212 Participants	13.68	-
1400 mg Donanemab - Cmaxn=213 Participants	18.31	-

Secondary/protocol endpoint

Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan

Time frame:Baseline, 76 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)

Time frame:24 Weeks

threshold achievement, improvement

Secondary/registry result

Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan

Time frame:Baseline, 76 Weeks

change from baseline, improvement

Secondary/registry result

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)

Time frame:24 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
1400 mg Donanemab - Standard Regimenn=207 Participants	25.12	-
1400 mg Donanemab - Dose Skippingn=210 Participants	22.86	-
1400 mg Donanemab - Titrationn=212 Participants	20.28	-
1400 mg Donanemab - Cmaxn=213 Participants	20.66	-

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetics (PK): Average Serum Concentration of Donanemab

Time frame:Baseline to 76 Weeks

concentration, descriptive

Secondary/registry result

Pharmacokinetics (PK): Average Serum Concentration of Donanemab

Time frame:Baseline to 76 Weeks

concentration, descriptive

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Percentage of Participants With Any Occurrence of ARIA-E

Time frame:52 Weeks

threshold achievement, improvement

Secondary/registry result/low confidence

Percentage of Participants With Any Occurrence of ARIA-E

Time frame:52 Weeks

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants With ARIA-H

Time frame:52 Weeks

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H

Time frame:76 Weeks

threshold achievement, improvement

Secondary/registry result/low confidence

Percentage of Participants With ARIA-H

Time frame:52 Weeks

threshold achievement, improvement

Secondary/registry result/low confidence

Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H

Time frame:76 Weeks

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies

Time frame:Baseline to End of Follow-Up (91 Weeks)

event count, event

Secondary/registry result/low confidence

Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies

Time frame:Baseline to End of Follow-Up (91 Weeks)

event count, event

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.