A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) - 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 ID17737

Eudract number2020-000077-25

Secondary IDI5T-MC-AACIEli Lilly and Company

NCT IDNCT04437511

Timeline

Milestones

Study first posted2020-06-18actual

Study start2020-06-19actual

Primary completion2023-04-14actual

Results first posted2024-05-20actual

Last update posted2025-08-29actual

Study completion2028-11estimated (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 participants or informants for ≥ 6 months

•MMSE score of 20 to 28 (inclusive) at baseline

•Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort

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

•Have a study partner who will provide written informed consent to participate

Exclusion criteria

•Contraindication to MRI or PET scans

•Current treatment with immunoglobulin G (IgG) therapy

Endpoints (30)

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

12

Function / daily living

8

Amyloid biomarkers

2

Tau biomarkers

2

Neuroimaging

2

Safety / tolerability / PK

2

Other (unclassified)

2

Global cognition

12 endpoints

Secondary/protocol endpoint

Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)

Time frame:Baseline, Week 76

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

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

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 Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

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

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)

Time frame:Baseline, Week 76

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=796 Participants	-2.47	0.14
Placebon=841 Participants	-2.94	0.13

LS Mean change difference (Final Values)0.4795% CI0.104 - 0.841p0.012Mixed Models Analysis

Secondary/registry result

Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=549 Participants	-1.61	0.14
Placebon=573 Participants	-2.09	0.14

LS Mean change difference (Final Values)0.4895% CI0.089 - 0.868p0.016Mixed Models Analysis

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=797 Participants	5.46	0.28
Placebon=841 Participants	6.79	0.27

LS Mean change difference (Final Values)-1.3395% CI-2.086 - -0.565p0.0006Mixed Models Analysis

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=550 Participants	3.17	0.27
Placebon=570 Participants	4.69	0.26

LS Mean change difference (Final Values)-1.5295% CI-2.250 - -0.794p<0.001Mixed Models Analysis

Secondary/registry result

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

Time frame:Baseline, Week 76

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
Donanemabn=794 Participants	1.72	0.096
Placebon=838 Participants	2.42	0.092

LS Mean change difference (Final Values)-0.7095% CI-0.95 - -0.45p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

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
Donanemabn=546 Participants	1.20	0.105
Placebon=569 Participants	1.88	0.102

LS Mean change difference (Final Values)-0.6795% CI-0.95 - -0.40p<0.001Mixed Models Analysis

Function / daily living

8 endpoints

Primary/protocol endpoint

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=775 Participants	-10.19	0.53
Placebon=824 Participants	-13.11	0.50

LS Mean change difference (Final Values)2.9295% CI1.508 - 4.331p<0.001Mixed Models Analysis

Primary/registry result

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=533 Participants	-6.02	0.50
Placebon=560 Participants	-9.27	0.49

LS Mean change difference (Final Values)3.2595% CI1.883 - 4.618p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)

Time frame:Baseline, Week 76

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)

Time frame:Baseline, Week 76

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=780 Participants	-4.42	0.32
Placebon=826 Participants	-6.13	0.30

LS Mean change difference (Final Values)1.7095% CI0.840 - 2.566p0.0001Mixed Models Analysis

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)

Time frame:Baseline, Week 76

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Donanemabn=535 Participants	-2.76	0.34
Placebon=562 Participants	-4.59	0.32

LS Mean change difference (Final Values)1.8395% CI0.913 - 2.748p<0.001Mixed Models Analysis

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 76

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 76

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centiloids	Standard error
Donanemabn=765 Participants	-87.03	0.950
Placebon=812 Participants	-0.67	0.909

LS Mean change difference (Final Values)-86.3795% CI-88.87 - -83.87p<0.0001Mixed 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, Week 76

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 76

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), standardized uptake value ratio (SUVR)	Standard error
Donanemabn=578 Participants	0.0401	0.00398
Placebon=654 Participants	0.0442	0.00374

LS Mean change difference (Final Values)-0.004195% CI-0.0148 - 0.0066p0.4522ANCOVA

Neuroimaging

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 76

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cubic centimeter (cm^3)	Standard error
DonanemabBilateral Hippocampusn=786 Participants	-0.20	0.005
Bilateral Whole Brainn=786 Participants	-27.46	0.409
Bilateral Ventriclesn=786 Participants	10.07	0.185
PlaceboBilateral Hippocampusn=831 Participants	-0.22	0.005
Bilateral Whole Brainn=831 Participants	-20.79	0.392
Bilateral Ventriclesn=831 Participants	7.05	0.178

LS Mean change difference (Final Values)0.0295% CI0.01 - 0.04p0.002Mixed Models Analysis

Bilateral Hippocampus

LS Mean change difference (Final Values)-6.6695% CI-7.76 - -5.56p<0.001Mixed Models Analysis

Bilateral Whole Brain

LS Mean change difference (Final Values)3.0295% CI2.52 - 3.52p<0.001Mixed Models Analysis

Bilateral Ventricles

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab

Time frame:Week 16 to week 20

concentration, descriptive

Secondary/registry result

Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab

Time frame:Week 16 to week 20

concentration, descriptive

Posted result

Group	Value (geometric_mean), micrograms per milliliter (μg/mL)	Geometric coefficient of variation
Donanemabn=853 Participants	63	32

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Number or Participants With Anti-Donanemab Antibodies

Time frame:Baseline through Week 76

event count, event

Secondary/registry result/low confidence

Number or Participants With Anti-Donanemab Antibodies

Time frame:Baseline through Week 76

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Donanemabn=793 Participants	693	-
Placebon=821 Participants	48	-

Publications (13)

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.