A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) - Alzheimer’s Disease & Related Dementias Atlas

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 ID16933

Secondary IDI5T-MC-AACGEli Lilly and Company

NCT IDNCT03367403

Timeline

Milestones

Study first posted2017-12-08actual

Study start2017-12-18actual

Primary completion2020-12-04actual

Study completion2021-09-21actual

Results first posted2022-02-15actual

Last update posted2026-03-19actual

Assets

Drug assets

Donanemab LY3202626

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 participants or informants for ≥ 6 months.

•MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.

•Meet 18F flortaucipir PET scan eligibility criteria.

•Meet 18F florbetapir PET scan (central read) eligibility criteria

Exclusion criteria

•Have a history of long QT syndrome.

•Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.

•Contraindication to MRI.

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

Global cognition

6

Function / daily living

4

Amyloid biomarkers

2

Tau biomarkers

2

Neuroimaging

2

Global cognition

6 endpoints

Secondary/protocol endpoint

Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, 76 Weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score

Time frame:Baseline, 76 Weeks

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Mini Mental State Examination (MMSE) Score

Time frame:Baseline, 76 Weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, 76 Weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemab Monotherapy (Donanemab-M)n=93 Participants	2.91	0.659
Placebon=93 Participants	4.77	0.660

Mean Difference (Final Values)-1.8695% CI-3.63 - -0.09p0.040Mixed Models Analysis

Secondary/registry result

Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score

Time frame:Baseline, 76 Weeks

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

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemab Monotherapy (Donanemab-M)n=93 Participants	1.22	0.176
Placebon=90 Participants	1.58	0.178

Mean Difference (Final Values)-0.3695% CI-0.83 - 0.12p0.139Mixed Models Analysis

Secondary/registry result

Change From Baseline in the Mini Mental State Examination (MMSE) Score

Time frame:Baseline, 76 Weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemab Monotherapy (Donanemab-M)n=91 Participants	-2.35	0.386
Placebon=90 Participants	-2.98	0.390

Mean Difference (Final Values)0.6495% CI-0.40 - 1.67p0.227Mixed Models Analysis

Function / daily living

4 endpoints

Primary/protocol endpoint

Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Time frame:Baseline, 76 Weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Time frame:Baseline, 76 Weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemab Monotherapy (Donanemab-M)n=93 Participants	-6.86	1.135
Placebon=91 Participants	-10.06	1.141

Mean Difference (Final Values)3.2095% CI0.12 - 6.27p0.042Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score

Time frame:Baseline, 76 Weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score

Time frame:Baseline, 76 Weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemab Monotherapy (Donanemab-M)n=93 Participants	-3.98	0.738
Placebon=91 Participants	-5.20	0.743

Mean Difference (Final Values)1.2195% CI-0.77 - 3.20p0.230Mixed Models Analysis

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan

Time frame:Baseline, 76 Weeks

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan

Time frame:Baseline, 76 Weeks

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centiloids	Standard error
Donanemab Monotherapy (Donanemab-M)n=90 Participants	-84.13	2.723
Placebon=91 Participants	0.93	2.739

Mean Difference (Final Values)-85.0695% CI-92.68 - -77.43p<0.001Mixed Models Analysis

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan

Time frame:Baseline, 76 Weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan

Time frame:Baseline, 76 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), standardized uptake value ratio (SUVR)	Standard error
Donanemab Monotherapy (Donanemab-M)Tau-IQn=90 Participants	0.55	0.007
MUBADA-Cerebellumn=89 Participants	1.54	0.009
PlaceboTau-IQn=87 Participants	0.55	0.007
MUBADA-Cerebellumn=84 Participants	1.58	0.010

Mean Difference (Final Values)0.0195% CI-0.01 - 0.03p0.560ANCOVA

Tau-IQ

Mean Difference (Final Values)0.03595% CI0.007 - 0.062p0.012ANCOVA

MUBADA-Cerebellum

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, 76 Weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, 76 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cubic centimeter (cm^3)	Standard error
Donanemab Monotherapy (Donanemab-M)Bilateral Corticaln=82 Participants	-11.18	0.447
Bilateral Entorhinal Cortexn=82 Participants	-0.17	0.008
Bilateral Hippocampusn=82 Participants	-0.22	0.013
Bilateral Inferior Parietal Loben=82 Participants	-0.53	0.033
Bilateral Isthmuscingulaten=82 Participants	-0.15	0.008
Bilateral Lateral Parietal Loben=82 Participants	-1.60	0.084
Bilateral Medial Temporal Loben=82 Participants	-0.73	0.025
Bilateral Precuneusn=82 Participants	-0.71	0.032
Bilateral Prefrontal Loben=82 Participants	-1.50	0.081
Bilateral Superior Temporal Loben=82 Participants	-0.73	0.031
Bilateral Ventriclesn=82 Participants	8.66	0.412
Bilateral Whole Brainn=82 Participants	-24.53	1.077
Bilateral Whole Temporal Loben=82 Participants	-3.52	0.126
Bilateral White Mattern=82 Participants	-11.03	0.700
PlaceboBilateral Corticaln=83 Participants	-8.51	0.445
Bilateral Entorhinal Cortexn=83 Participants	-0.17	0.008
Bilateral Hippocampusn=83 Participants	-0.22	0.013
Bilateral Inferior Parietal Loben=83 Participants	-0.45	0.033
Bilateral Isthmuscingulaten=83 Participants	-0.13	0.008
Bilateral Lateral Parietal Loben=83 Participants	-1.26	0.083
Bilateral Medial Temporal Loben=83 Participants	-0.72	0.025
Bilateral Precuneusn=83 Participants	-0.55	0.032
Bilateral Prefrontal Loben=83 Participants	-1.11	0.080
Bilateral Superior Temporal Loben=83 Participants	-0.52	0.031
Bilateral Ventriclesn=83 Participants	6.38	0.410
Bilateral Whole Brainn=83 Participants	-19.95	1.072
Bilateral Whole Temporal Loben=83 Participants	-2.84	0.126
Bilateral White Mattern=83 Participants	-8.75	0.696

Mean Difference (Final Values)-2.6795% CI-3.92 - -1.43p< 0.001Mixed Models Analysis

Bilateral Cortical

Mean Difference (Final Values)-0.0095% CI-0.02 - 0.02p0.916Mixed Models Analysis

Bilateral Entorhinal Cortex

Mean Difference (Final Values)0.0195% CI-0.03 - 0.04p0.771Mixed Models Analysis

Mean Difference (Final Values)-0.0895% CI-0.17 - 0.01p0.094Mixed Models Analysis

Bilateral Inferior Parietal Lobe

Mean Difference (Final Values)-0.0295% CI-0.04 - 0.00p0.052Mixed Models Analysis

Bilateral Isthmuscingulate

Mean Difference (Final Values)-0.3495% CI-0.57 - -0.11p0.005Mixed Models Analysis

Bilateral Lateral Parietal Lobe

Mean Difference (Final Values)-0.0195% CI-0.08 - 0.06p0.731Mixed Models Analysis

Bilateral Medial Temporal Lobe

Mean Difference (Final Values)-0.1695% CI-0.25 - -0.07p<0.001Mixed Models Analysis

Bilateral Precuneus

Mean Difference (Final Values)-0.4095% CI-0.62 - -0.17p<0.001Mixed Models Analysis

Bilateral Prefrontal Lobe

Mean Difference (Final Values)-0.2195% CI-0.30 - -0.12p<0.001Mixed Models Analysis

Bilateral Superior Temporal Lobe

Mean Difference (Final Values)2.2895% CI1.14 - 3.43p< 0.001Mixed Models Analysis

Bilateral Ventricles

Mean Difference (Final Values)-4.5895% CI-7.58 - -1.59p0.003Mixed Models Analysis

Bilateral Whole Brain

Mean Difference (Final Values)-0.6895% CI-1.03 - -0.33p<0.001Mixed Models Analysis

Bilateral Whole Temporal Lobe

Mean Difference (Final Values)-2.2895% CI-4.23 - -0.33p0.022Mixed Models Analysis

Bilateral White Matter

Publications (8)

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.