ExpeditionPRO

TerminatedPhase 3Results posted

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Solanezumab

Listed sites

193

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•prodromal AD•Amyloid biomarker required (PET/CSF)•MoCA 17-28•MRI contraindications excluded

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 ID16349

Eudract number2016-000108-27

Secondary IDH8A-MC-LZBEEli Lilly and Company

NCT IDNCT02760602

Timeline

Milestones

Study first posted2016-05-03estimated

Study start2016-06 (month precision)

Primary completion2017-05actual (month precision)

Study completion2017-05actual (month precision)

Results first posted2018-07-24actual

Last update posted2019-10-10actual

Assets

Drug assets

Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.

•Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.

•Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.

•Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).

•Scores >0 on the Functional Activities Questionnaire (FAQ).

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

Exclusion criteria

•Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.

•Has known allergy to humanized monoclonal antibodies.

•Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.

•Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.

•Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.

•Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)

Endpoints (34)

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

Memory

Amyloid biomarkers

Function / daily living

Behavior / neuropsychiatric

Neuroimaging

Caregiver / quality of life

Other (unclassified)

Global cognition

8 endpoints

Secondary/protocol endpoint

Change From Baseline on the Mini Mental Status Examination (MMSE)

Time frame:Baseline, 24 Months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Montreal Cognitive Assessment (MoCA)

Time frame:Baseline, 24 Months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 24 Months

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Mini Mental Status Examination (MMSE)

Time frame:Baseline, 24 Months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Montreal Cognitive Assessment (MoCA)

Time frame:Baseline, 24 Months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, 24 Months

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

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame:Baseline, 24 Months

change from baseline, improvement

Memory

6 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score

Time frame:Baseline, 24 Months

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score

Time frame:Baseline, 24 Months

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, 24 Months

change from baseline, improvement

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Functional Activities Questionnaire (FAQ)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Functional Activities Questionnaire (FAQ)

Time frame:Baseline, 24 Months

change from baseline, improvement

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Baseline on the Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 24 Months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 24 Months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)

Time frame:Baseline, 24 Months

change from baseline, improvement

Amyloid biomarkers

6 endpoints

Secondary/protocol endpoint

Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins

Time frame:Baseline, 24 Months

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins

Time frame:Baseline, 24 Months

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, 24 Months

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, 24 Months

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET

Time frame:Baseline, 24 Months

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET

Time frame:Baseline, 24 Months

change from baseline, improvement

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.