CompletedPhase 2Results posted

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•ADAS-Cog•Part B

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 ID17447

Secondary IDI5T-MC-AACHEli Lilly and Company

NCT IDNCT04640077

Timeline

Milestones

Study first posted2020-11-23actual

Study start2020-11-23actual

Primary completion2024-02-27actual

Study completion2024-02-27actual

Last update posted2025-06-13actual

Results first posted2025-06-13actual

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.

•Have a study partner

•Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A

Exclusion criteria

•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 outcome assessments or the analyses in this study.

•Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study.

•Poor venous access

•Contraindication to PET or MRI imaging

Endpoints (24)

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

Safety / tolerability / PK

Function / daily living

Amyloid biomarkers

Neuroimaging

Other (unclassified)

Global cognition

10 endpoints

Primary/protocol endpoint

Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments

Time frame:Baseline to 4 Weeks

ADAS-Cog

descriptive

Primary/registry result

Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments

Time frame:Baseline to 4 Weeks

ADAS-Cog

descriptive

Posted result

Group	Value (number), Intraclass correlation coefficient	Reported bounds
Part A: Validation of Remote Scale AssessmentsADAS-Cog13n=81 Participants	0.8172	-0.7293 - 0.8785
ADCS-ADLn=82 Participants	0.8819	-0.8227 - 0.9222
MMSEn=84 Participants	0.8251	-0.7148 - 0.8907
CDR-SBn=80 Participants	0.8254	-0.7380 - 0.8852

Secondary/protocol endpoint

Part B: Change From Baseline on the Mini Mental State Examination (MMSE) Score

Time frame:Baseline, Week 72

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 72

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 72

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Time frame:Baseline, Week 72

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

change from baseline, improvement

Secondary/registry result

Part B: Change From Baseline on the Mini Mental State Examination (MMSE) Score

Time frame:Baseline, Week 72

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Part B: Donanemabn=55 Participants	-0.87	0.557

Secondary/registry result

Part B: Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 72

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Part B: Donanemabn=55 Participants	4.63	1.195

Secondary/registry result

Part B: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 72

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Part B: Donanemabn=55 Participants	-10.14	1.850

Secondary/registry result

Part B: Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Time frame:Baseline, Week 72

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
Part B: Donanemabn=55 Participants	1.87	0.364

Function / daily living

2 endpoints

Secondary/protocol endpoint

Part B: Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL)

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/registry result

Part B: Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL)

Time frame:Baseline, Week 72

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Part B: Donanemabn=55 Participants	-6.21	1.149

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 36

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 36

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centiloids	Standard error
Part B: Donanemabn=36 Participants	-80.1	4.40

Neuroimaging

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 72

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cubic centimeters (cm3)	Standard error
Part B: Donanemabn=55 Participants	-27.75	2.060

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:Baseline Up To 96 Weeks

threshold achievement, event

Primary/protocol endpoint

Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline, Week 72

event count, event

Primary/registry result

Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:Baseline Up To 96 Weeks

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Part B: DonanemabTEAEsn=55 Participants	90.9	-
SAEsn=55 Participants	29.1	-

Primary/registry result

Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline, Week 72

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part B: DonanemabSuicidal Ideationn=53 Participants	3	-
Suicidal Behaviorn=53 Participants	1	-

Secondary/protocol endpoint

Part B: Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough)

Time frame:Predose at Week 8 and Week 16

concentration, descriptive

Secondary/registry result

Part B: Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough)

Time frame:Predose at Week 8 and Week 16

concentration, descriptive

Posted result

Group	Value (geometric_mean), micrograms per milliliter (μg/mL)	Geometric coefficient of variation
Part B: DonanemabCtrough at Week 8n=53 Participants	5.62	165
Ctrough at Week 16n=39 Participants	6.64	581

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Part B: Number or Participants With Treatment-Emergent Anti-Drug Antibodies (TE ADA) of Donanemab

Time frame:Baseline, 4, 8, 16, 24, 36, 48, 60, 72, 84, and 96 Weeks

event count, event

Secondary/registry result/low confidence

Part B: Number or Participants With Treatment-Emergent Anti-Drug Antibodies (TE ADA) of Donanemab

Time frame:Baseline, 4, 8, 16, 24, 36, 48, 60, 72, 84, and 96 Weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part B: Donanemabn=47 Participants	38	-

Publications (2)

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.