Recruiting

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

6,250

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/CSF)•Tau biomarker required (PET/CSF)•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•First Increase in Dependence Level Above Baseline

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 ID18721

Secondary IDI5T-MC-AACSEli Lilly and Company

NCT IDNCT06566170

Timeline

Milestones

Study first posted2024-08-22actual

Study start2024-10-07actual

Last update posted2025-10-09actual

Primary completion2033-02estimated (month precision)

Study completion2033-02estimated (month precision)

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Participants

•are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records [EHR] is required prior to screening)

•have a Telephone Interview for Cognitive Status (TICS) score of ≥21

•presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid [CSF]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)

•have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and

•have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study

Exclusion criteria

•have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)

•have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (>12 months) institutional-level care, serious psychiatric illness, etc.)

•are currently enrolled or intend to enroll in a clinical trial of another investigational product, and

•have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).

Endpoints (10)

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)

Function / daily living

Caregiver / quality of life

Behavior / neuropsychiatric

Disease progression

Function / daily living

2 endpoints

Secondary/protocol endpoint

Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline

Time frame:Up to 5 Years

time to event, event

Secondary/protocol endpoint

Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score

Time frame:Baseline, Up to 5 Years

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score

Time frame:Baseline, Up to 5 Years

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Disease progression

1 endpoint

Secondary/protocol endpoint

Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline

Time frame:Up to 5 Years

time to event, event

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])

Time frame:Up to 5 Years

time to event, event

Secondary/protocol endpoint

Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score

Time frame:Baseline, Up to 5 Years

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change from Baseline Over Time (Semi-Annually) in DS Total Score

Time frame:Baseline, Up to 5 Years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline Over Time (Assessed Semi-Annually) in Living Situation as Assessed by the Participant Lifestyle Questionnaire (P-LSQ)

Time frame:Baseline, Up to 5 Years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ

Time frame:Baseline, Up to 5 Years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ

Time frame:Baseline, Up to 5 Years

change from baseline, improvement

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.