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A4

CompletedPhase 3Results posted

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)

Asset

Solanezumab

Listed sites

68

Recruiting sites

-

Enrollment

1,169

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required (PET)•CDR global 0•MMSE 25-30•Study partner/caregiver required

Primary endpoint

•Mini-Mental State Examination (MMSE)

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 ID15275
Secondary IDH8A-MC-LZAZEli Lilly and Company
NCT IDNCT02008357

Timeline

Milestones

Study first posted2013-12-11estimated
Study start2014-02-28actual
Primary completion2022-12-27actual
Study completion2023-06-08actual
Last update posted2023-12-28actual
Results first posted2023-12-28actual

Assets

Drug assets

Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30
•Has a global Clinical Dementia Rating (CDR) scale score at screening of 0
•Has a Logical Memory II score at screening of 6 to 18
•Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening
•Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)

Exclusion criteria

•Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline
•Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded
•Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
•Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness
•Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment
•Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
•Is clinically judged by the investigator to be at serious risk for suicide
•Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)
•Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM

Open-Label Inclusion Criteria:

•All participants who complete the placebo-controlled period will be allowed to continue into the open-label period

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
12
Amyloid biomarkers
6
Function / daily living
4
Tau biomarkers
2

Global cognition

12 endpoints
Primary/protocol endpoint

Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score

Time frame:Baseline, Week approximately 240

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score

Time frame:Baseline, Week 336

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score

Time frame:Baseline, Week approximately 240

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
Solanezumabn=403 Participants-1.430.21
Placebon=426 Participants-1.130.16
LS Mean difference (Final Values)-0.3095% CI-0.816 - 0.220p0.260Natural Cubic Spline (NCS) method
Primary/registry result

Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score

Time frame:Baseline, Week 336

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Cognitive Function Index (CFI)

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Cognitive Function Index (CFI)

Time frame:Baseline, Week 336

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 336

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Computerized Cognitive Composite (C3)

Time frame:Baseline, Week 336

change from baseline, improvement

Secondary/registry result

Change From Baseline in Cognitive Function Index (CFI)

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
Solanezumabn=408 Participants1.940.20
Placebon=422 Participants1.470.20
LS Mean difference (Final Values)0.4795% CI-0.089 - 1.020p0.100Natural Cubic Spline (NCS) method
Secondary/registry result

Change From Baseline in Cognitive Function Index (CFI)

Time frame:Baseline, Week 336

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 336

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

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Computerized Cognitive Composite (C3)

Time frame:Baseline, Week 336

change from baseline, improvement

Function / daily living

4 endpoints
Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score

Time frame:Baseline, Week approximately 240

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score

Time frame:Baseline, Week 336

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score

Time frame:Baseline, Week approximately 240

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
Solanezumabn=408 Participants-2.290.24
Placebon=423 Participants-1.700.24
LS Mean difference (Final Values)-0.5995% CI-1.265 - 0.076p0.082Natural Cubic Spline (NCS) method
Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score

Time frame:Baseline, Week 336

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Amyloid biomarkers

6 endpoints
Secondary/protocol endpoint

Change From Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aβ)

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), standardized uptake value ratio (SUVr)Standard error
Solanezumabn=462 Participants0.0660.0052
Placebon=477 Participants0.1080.0051
LS Mean difference (Final Values)-0.04295% CI-0.057 - -0.028p<0.001ANCOVA
Secondary/registry result

Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aβ)

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), nanograms per liter (ng/L)Standard error
SolanezumabCSF Amyloid Beta 1-40 Modified ELISA - INNOTESTn=51 Participants12151.386711.6120
CSF Amyloid Beta 1-42 Mod Modified ELISA - INNOTESTn=51 Participants1045.57042.6843
PlaceboCSF Amyloid Beta 1-40 Modified ELISA - INNOTESTn=54 Participants-587.063691.2989
CSF Amyloid Beta 1-42 Mod Modified ELISA - INNOTESTn=52 Participants49.16042.2627
LS Mean difference (Final Values)12738.44995% CI10757.047 - 14719.851p<0.001ANCOVA

Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST

LS Mean difference (Final Values)996.41195% CI875.873 - 1116.948p<0.001ANCOVA

Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST

Secondary/registry result

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

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), cubic centimeter (cm^3)Standard error
SolanezumabTotal hippocampal volumen=561 Participants-0.3690.0276
Total Lateral Ventricular Volumen=561 Participants9.3290.3215
PlaceboTotal hippocampal volumen=578 Participants-0.3140.0272
Total Lateral Ventricular Volumen=578 Participants8.9780.3167
LS Mean difference (Final Values)-0.05495% CI-0.131 - 0.022p0.161ANCOVA

Total hippocampal volume

LS Mean difference (Final Values)0.35195% CI-0.535 - 1.236p0.437ANCOVA

Total Lateral Ventricular Volume

Tau biomarkers

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Secondary/registry result

Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers

Time frame:Baseline, Week approximately 240

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), nanograms per liter (ng/L)Standard error
SolanezumabCSF Tau Proteinn=48 Participants-17.20123.5807
CSF Phosphorylated Tau Proteinn=44 Participants10.2661.8792
PlaceboCSF Tau Proteinn=52 Participants-20.44022.6457
CSF Phosphorylated Tau Proteinn=46 Participants11.2311.8371
LS Mean difference (Final Values)3.23995% CI-62.020 - 68.498p0.922ANCOVA

Cerebrospinal fluid Tau Protein Immunoassay

LS Mean difference (Final Values)-0.96595% CI-6.241 - 4.311p0.717ANCOVA

Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay

Publications (12)

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.