EXPEDITION EXT

TerminatedPhase 3Results posted

Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease

Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Solanezumab

Listed sites

147

Recruiting sites

Enrollment

1,457

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Assess the Number of Participants With One or More Drug-Related Adverse Events

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 ID11935

Secondary IDH8A-MC-LZAOEli Lilly and Company

NCT IDNCT01127633

Timeline

Milestones

Study first posted2010-05-21estimated

Study start2010-12 (month precision)

Primary completion2014-07actual (month precision)

Study completion2017-02actual (month precision)

Results first posted2018-05-03actual

Last update posted2019-10-08actual

Assets

Drug assets

Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease

•Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks

•Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study

•Must have good vein access to administer infusions

•Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Exclusion criteria

•Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

•Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

Endpoints (26)

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

Behavior / neuropsychiatric

Memory

Function / daily living

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

14 endpoints

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Time frame:Baseline, Week 104

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels

Time frame:Baseline, Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=409 Participants	17.58	0.532
Solanezumabn=451 Participants	17.56	0.517

Median Difference (Net)-0.0295% CI-1.14 - 1.11p0.974Mixed Models Analysis

Secondary/registry result

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=420 Participants	-26.77	0.888
Solanezumabn=456 Participants	-24.77	0.871

Secondary/registry result

Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Time frame:Baseline, Week 104

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

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=416 Participants	5.59	0.174
Solanezumabn=452 Participants	5.27	0.169

Secondary/registry result

Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=412 Participants	-8.08	0.270
Solanezumabn=446 Participants	-7.60	0.263

Secondary/registry result

Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels

Time frame:Baseline, Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picograms per milliliter (pg/mL)	Standard error
PlaceboAβ 1-40-Mild Alzheimer's Diseasen=358 Participants	176412.04	3718.292
Aβ 1-42-Mild Alzheimer's Diseasen=356 Participants	19854.92	366.392
Aβ 1-40-Moderate Alzheimer's Diseasen=157 Participants	169356	4627.8
Aβ 1-42-Moderate Alzheimer's Diseasen=157 Participants	19237	556.3
SolanezumabAβ 1-40-Mild Alzheimer's Diseasen=357 Participants	173064.99	3717.695
Aβ 1-42-Mild Alzheimer's Diseasen=356 Participants	19723.48	368.644
Aβ 1-40-Moderate Alzheimer's Diseasen=174 Participants	169087	4511.6
Aβ 1-42-Moderate Alzheimer's Diseasen=176 Participants	19552	528.7

Secondary/registry result

Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Cubic millimeter (mm³)	Standard error
PlaceboRight hippocampal volume-Mild Alzheimer's Diseasen=227 Participants	-230.23	8.232
Left hippocampal volume-Mild Alzheimer's Diseasen=227 Participants	-257.15	8.153
Right hippocampal volume-Moderate Alzheimer'sn=83 Participants	-261.39	11.796
Left hippocampal volume-Moderate Alzheimer'sn=83 Participants	-255.16	11.466
SolanezumabRight hippocampal volume-Mild Alzheimer's Diseasen=231 Participants	-230.07	8.195
Left hippocampal volume-Mild Alzheimer's Diseasen=231 Participants	-244.00	8.115
Right hippocampal volume-Moderate Alzheimer'sn=94 Participants	-256.52	11.246
Left hippocampal volume-Moderate Alzheimer'sn=94 Participants	-253.29	10.858

Secondary/registry result

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=375 Participants	17.78	0.595
Solanezumabn=409 Participants	17.38	0.580

Memory

2 endpoints

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/registry result

Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)

Time frame:Baseline, Week 104

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
PlaceboQLAD Self-Report Total Score-Mild Alzheimer'sn=273 Participants	-1.37	0.331
QLAD Caregiver Total Score-Mild Alzheimer'sn=284 Participants	-3.28	0.350
QLAD Self-Report Total Score-Moderate Alzheimer'sn=88 Participants	-2.52	0.605
QLAD Caregiver Total Score-Moderate Alzheimer'sn=103 Participants	-4.26	0.573
SolanezumabQLAD Self-Report Total Score-Mild Alzheimer'sn=283 Participants	-0.98	0.327
QLAD Caregiver Total Score-Mild Alzheimer'sn=299 Participants	-3.63	0.345
QLAD Self-Report Total Score-Moderate Alzheimer'sn=94 Participants	-2.34	0.585
QLAD Caregiver Total Score-Moderate Alzheimer'sn=114 Participants	-3.14	0.552

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/registry result

Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours

Time frame:Baseline, Week 104

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), hours per day (hr/day)	Standard error
PlaceboMild Alzheimer's Disease-Basic ADLn=302 Participants	1.96	0.184
Mild Alzheimer's Disease-Instrumental ADLn=303 Participants	1.65	0.207
Mild Alzheimer's Disease-Supervisionn=303 Participants	2.84	0.368
Moderate Alzheimer's Disease-Basic ADLn=112 Participants	3.19	0.461
Moderate Alzheimer's Disease-Instrumental ADLn=112 Participants	1.75	0.461
Moderate Alzheimer's Disease-Supervisionn=112 Participants	5.03	0.693
SolanezumabMild Alzheimer's Disease-Basic ADLn=319 Participants	1.21	0.182
Mild Alzheimer's Disease-Instrumental ADLn=319 Participants	1.05	0.205
Mild Alzheimer's Disease-Supervisionn=319 Participants	2.59	0.361
Moderate Alzheimer's Disease-Basic ADLn=132 Participants	3.54	0.436
Moderate Alzheimer's Disease-Instrumental ADLn=132 Participants	1.72	0.433
Moderate Alzheimer's Disease-Supervisionn=132 Participants	4.47	0.654

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/registry result

Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
PlaceboMild Alzheimer's Diseasen=302 Participants	4.49	0.788
Moderate Alzheimer's Diseasen=112 Participants	11.90	1.517
SolanezumabMild Alzheimer's Diseasen=323 Participants	5.41	0.773
Moderate Alzheimer's Diseasen=134 Participants	8.10	1.427

Secondary/registry result

Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)

Time frame:Baseline, Week 104

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
PlaceboMild Alzheimer's Diseasen=303 Participants	-0.07	0.010
Moderate Alzheimer's Diseasen=111 Participants	-0.16	0.020
SolanezumabMild Alzheimer's Diseasen=320 Participants	-0.06	0.009
Moderate Alzheimer's Diseasen=133 Participants	-0.16	0.019

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease

Time frame:Baseline, Week 104

change from baseline, improvement

Posted result

Group	Value (mean), Standard Uptake Value ratio (SUVr)	Standard deviation
Placebon=42 Participants	0.00	0.131
Solanezumabn=48 Participants	-0.01	0.222

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)

Time frame:Baseline through Week 104

event count, event

Primary/registry result

Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)

Time frame:Baseline through Week 104

event count, event

Posted result

Group	Value (number), participants	Reported bounds
PlaceboSAEn=723 Participants	308	-
Other AEn=723 Participants	485	-
SolanezumabSAEn=734 Participants	299	-
Other AEn=734 Participants	514	-

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.