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RecruitingPhase 2

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Asset

Donanemab

Listed sites

72

Recruiting sites

10

Enrollment

350

estimated

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•Amyloid biomarker required (CSF)•MoCA ≥20•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 ID27790
Secondary IDI5T-MC-AACVEli Lilly and Company
NCT IDNCT07589595

Timeline

Milestones

Study first posted2026-05-15actual
Study start2026-05-20actual
Last update posted2026-07-07actual
Primary completion2028-08estimated (month precision)
Study completion2028-08estimated (month precision)

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
•Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
•Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
•Meet plasma P-tau217 criteria.
•Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
•Have a CSF result consistent with the presence of alpha-synuclein pathology.
•Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities

Exclusion criteria

•Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
•Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
•Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
•Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
•Have previously received amyloid-targeting therapy.
•Active immunization against amyloid-beta.
•Have a centrally read MRI that does not meet study entry criteria.
•Have contraindication to MRI or PET scans.
•Have any contraindication to lumbar puncture.

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)
6
Global cognition
2
Function / daily living
1
Amyloid biomarkers
1

Global cognition

2 endpoints
Primary/protocol endpoint

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

Time frame:Baseline through Week 52

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

change from baseline, improvement

Secondary/protocol endpoint

Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)

Time frame:Baseline through Week 52

time to event, event

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)

Time frame:Baseline through Week 52

change from baseline, improvement

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Brain Amyloid Plaque Levels

Time frame:Baseline through Week 52

change from baseline, improvement

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

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

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)

Time frame:Baseline through Week 52

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Trough Concentration at Steady State

Time frame:Baseline through Week 52

concentration, descriptive

Secondary/protocol endpoint/low confidence

Maximum Concentration at Steady State

Time frame:Baseline through Week 52

concentration, descriptive

Secondary/protocol endpoint/low confidence

Antidrug Antibodies (ADA) Against Donanemab

Time frame:Baseline through Week 52

descriptive

Secondary/protocol endpoint/low confidence

Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants

Time frame:Baseline through Week 52

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.