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Active not recruitingPhase 3

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

141

Recruiting sites

Enrollment

1,500

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 20-28•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

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 ID18442

Ctis2025-522340-40-00

Secondary IDI5T-MC-AACOEli Lilly and Company

NCT IDNCT05508789

Timeline

Milestones

Study first posted2022-08-19actual

Study start2022-10-10actual

Last update posted2026-07-16actual

Primary completion2028-05estimated (month precision)

Study completion2028-07estimated (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 MMSE score of 20 to 28 (inclusive) at screening visit.

•Meet amyloid scan (central read) criteria.

•Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.

•A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.

•If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.

•Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

-AEs and concomitant medications

-CDR, and

-ADCS-ADL

•Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization

Exclusion criteria

•Has 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; or has a life expectancy of <24 months.

•History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.

•Contraindication to MRI or PET scans.

Endpoints (9)

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)

Global cognition

Function / daily living

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

Time frame:Baseline, Week 76

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

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on the Mini Mental State Examination (MMSE) Score

Time frame:Baseline, Week 76

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score

Time frame:Baseline, Week 76

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 76

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics (PK): Trough Serum Concentration of Donanemab

Time frame:Baseline to Week 76

concentration, descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline on the iADRS

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)

Time frame:Week 76

event count, event

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.