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EXPEDITION 3

TerminatedPhase 3Results posted

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo

Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

Lead sponsor

Eli Lilly and Company

Asset

Solanezumab

Listed sites

198

Recruiting sites

Enrollment

2,129

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/CSF)•MMSE 20-26

Primary endpoint

•ADAS-Cog

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 ID15136

Secondary IDH8A-MC-LZAXEli Lilly and Company

NCT IDNCT01900665

Timeline

Milestones

Study start2013-07 (month precision)

Study first posted2013-07-16estimated

Primary completion2016-10actual (month precision)

Study completion2017-02actual (month precision)

Results first posted2018-03-14actual

Last update posted2019-10-09actual

Assets

Drug assets

Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 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 AD

•Has a Modified Hachinski Ischemia Scale score of less than or equal to 4

•Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit

•Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form)

•Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD

•Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening

Exclusion criteria

•Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications

•Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia

•Has 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 the analyses of safety and efficacy in this study; or has a life expectancy of <2 years

•Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness

•Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment

•Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions

•Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments

•Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks

•Has a history of chronic alcohol or drug abuse/dependence within the past 5 years

•Has a Visit 1 MRI with results showing >4 Amyloid-related Imaging Abnormality (ARIA), -hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)

Endpoints (36)

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

Function / daily living

Memory

Behavior / neuropsychiatric

Amyloid biomarkers

Neuroimaging

Fluid / digital biomarkers

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

10 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=1053 Participants	6.65	0.355
Placebon=1067 Participants	7.44	0.356

Mean Difference (Final Values)-0.8095% CI-1.73 - 0.14p0.095Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline, Week 80

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

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

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline, Week 80

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=893 Participants	-3.17	0.154
Placebon=876 Participants	-3.66	0.156

Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 80

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

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Solanezumabn=903 Participants	1.91	2.442
Placebon=895 Participants	2.23	2.692

Secondary/protocol endpoint

Percentage of Participants of Cognitive and Functional Responders

Time frame:Baseline through Week 80

ADAS-Cog

threshold achievement, improvement

Secondary/registry result

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

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Solanezumabn=903 Participants	-12.92	0.533
Placebon=883 Participants	-14.59	0.537

Secondary/registry result

Percentage of Participants of Cognitive and Functional Responders

Time frame:Baseline through Week 80

ADAS-Cog

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
SolanezumabCognitive Responders: Cut-off 6n=1057 Participants	35.7	-
Cognitive Responders: Cut-off 9n=1057 Participants	55.2	-
Functional Respondersn=1057 Participants	38.0	-
PlaceboCognitive Responders: Cut-off 6n=1072 Participants	35.3	-
Cognitive Responders: Cut-off 9n=1072 Participants	52.3	-
Functional Respondersn=1072 Participants	36.8	-

Memory

4 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=1053 Participants	5.22	0.284
Placebon=1067 Participants	5.90	0.285

Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=853 Participants	-0.55	0.158
Placebon=812 Participants	-0.72	0.161

Function / daily living

6 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Functional Activities Questionnaire (FAQ)

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 80

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=908 Participants	-6.17	0.318
Placebon=896 Participants	-7.17	0.320

Secondary/registry result

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

Time frame:Baseline, Week 80

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=908 Participants	-7.42	0.386
Placebon=897 Participants	-8.77	0.387

Secondary/registry result

Change From Baseline in Functional Activities Questionnaire (FAQ)

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=907 Participants	5.17	0.212
Placebon=892 Participants	5.57	0.213

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, Week 80

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, Week 80

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Solanezumabn=909 Participants	2.26	3.11
Placebon=891 Participants	0.382	0.387

Secondary/registry result

Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Solanezumabn=904 Participants	-1.10	0.556
Placebon=892 Participants	-2.61	0.562

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Plasma Amyloid-Beta (Aβ) Species

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

Change From Baseline in Plasma Amyloid-Beta (Aβ) Species

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Picogram/milliliter	Standard error
SolanezumabModified amyloid beta 1-40n=841 Participants	172754.36	1613.534
Modified amyloid beta1-42n=848 Participants	18485.26	104.913
PlaceboModified amyloid beta 1-40n=842 Participants	262.98	1609.006
Modified amyloid beta1-42n=840 Participants	15.75	105.237

Secondary/registry result

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), standard uptake value ratio	Standard error
SolanezumabSubject specific white matter correctedn=805 Participants	0.02	0.002
Mean whole cerebellum correctedn=805 Participants	-0.01	0.005
PlaceboSubject specific white matter correctedn=791 Participants	0.02	0.002
Mean whole cerebellum correctedn=791 Participants	0.00	0.005

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (mean), Cubic millimeter (mm^3)	Standard deviation
SolanezumabRight hippocampal atrophyn=789 Participants	-145.7	75.42
Left hippocampal atrophyn=789 Participants	-142.3	74.27
Right hippocampal atrophy+Left hippocampal atrophyn=789 Participants	-288.0	135.19
Right entorhinal cortex atrophyn=789 Participants	-77.3	45.18
Left entorhinal cortex atrophyn=789 Participants	-91.6	47.60
Right+Left entorhinal cortex atrophyn=789 Participants	-169.0	79.65
Atrophy of whole brain volumen=786 Participants	-22725.6	11920.78
Enlargement of Ventricular volumen=788 Participants	7055.4	4580.36
PlaceboRight hippocampal atrophyn=771 Participants	-154.1	81.06
Left hippocampal atrophyn=771 Participants	-146.3	78.04
Right hippocampal atrophy+Left hippocampal atrophyn=771 Participants	-300.4	138.52
Right entorhinal cortex atrophyn=771 Participants	-80.8	45.16
Left entorhinal cortex atrophyn=771 Participants	-95.2	53.46
Right+Left entorhinal cortex atrophyn=771 Participants	-176.0	86.11
Atrophy of whole brain volumen=769 Participants	-23500.5	12000.09
Enlargement of Ventricular volumen=770 Participants	7226.6	4545.73

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picogram/milliliter	Standard error
SolanezumabFree amyloid beta 1-42, CSFn=1057 Participants	-37.33	7.507
Modified amyloid beta 1-42, CSFn=1057 Participants	315.69	42.620
PlaceboFree amyloid beta 1-42, CSFn=1072 Participants	-9.27	8.175
Modified amyloid beta 1-42, CSFn=1072 Participants	-107.91	42.907

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/registry result

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)

Time frame:Baseline, Week 80

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Number of hospitalizations	Standard error
SolanezumabBasic ADLn=909 Participants	0.34	0.058
Instrumental ADLn=909 Participants	0.55	0.099
Sum of Basic and Instrumental ADLn=909 Participants	0.91	0.132
Supervisionn=909 Participants	0.72	0.125
PlaceboBasic ADLn=891 Participants	0.35	0.058
Instrumental ADLn=891 Participants	0.50	0.100
Sum of Basic and Instrumental ADLn=891 Participants	0.86	0.134
Supervisionn=891 Participants	0.88	0.127

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)

Time frame:Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion

concentration, descriptive

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)

Time frame:Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion

concentration, descriptive

Posted result

Group	Value (geometric_mean), milligramhour per milliliter (mgh/mL)	Geometric coefficient of variation
Solanezumabn=1044 Participants	43.2	24.3

Publications (3)

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.