CompletedPhase 2

A Biomarker Study of Solanezumab in Patients With and Without Alzheimer's

Plasma Amyloid Beta Species After a Single Solanezumab Infusion in Nondemented Individuals and Those With Mild Dementia of the Alzheimer's Type

Lead sponsor

Eli Lilly and Company

Asset

Solanezumab

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE 29-30

Primary endpoint

•Plasma levels of Aβ fragment-2 in (Group 1) and (Group 3)

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 ID13572

Secondary IDH8A-MC-LZATEli Lilly and Company

NCT IDNCT01148498

Timeline

Milestones

Study first posted2010-06-22estimated

Study start2010-08 (month precision)

Primary completion2012-08actual (month precision)

Study completion2012-08actual (month precision)

Last update posted2012-09-25estimated

Assets

Drug assets

Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age90 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

Individuals in Groups 1, 2, and 3, described below, will be participants in the longitudinal studies of memory and aging at the Washington University Alzheimer's Disease Research Center (WU-ADRC). These participants must have results from apolipoprotein E (ApoE) genotyping from the WU-ADRC. At the beginning of the study they must be between 45 and 90 years of age and if a female of childbearing potential, not be breastfeeding, test negative for pregnancy, and be using a medically accepted form of birth control at the time of the infusion and for 6 months afterward. Subjects must also meet the criteria below for each study group

Group 1, Mild dementia of Alzheimer's type (DAT):

•Have mild DAT, as determined by Clinical Dementia Rating (CDR) of 0.5 or 1

•Have florbetapir PET imaging findings consistent with underlying AD pathology.

Group 2, Older Adult Controls with Possible AD Pathology:

Have no cognitive impairment as indicated by a CDR rating of 0. Have possible AD pathology, as determined by florbetapir PET imaging.

Group 3, Older Adult Controls with No Evidence of AD Pathology:

Have no cognitive impairment as indicated by a CDR rating of 0. Have no evidence of AD pathology as determined by florbetapir PET imaging.

Individuals recruited into Group 4 will not be participants in the longitudinal studies of memory and aging at WU-ADRC. To be included in Group 4, individuals must meet these criteria:

•Are at least 18 years and <35 years of age at the beginning of the study and if a female of childbearing potential, is not breastfeeding, tests negative for pregnancy and is using highly effective contraception at the time of the solanezumab infusion and for 6 months following infusion

•Have a Folstein Mini-Mental State Examination (MMSE) score of 29 to 30 at the beginning of the study

Exclusion criteria

•Have previously completed or withdrawn from this study or any other study investigating solanezumab

•Does not have good venous access, such that intravenous drug delivery or multiple blood draws would be precluded

•Has allergies to humanized monoclonal antibodies

•Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

•Has a history of chronic alcohol or drug abuse/dependence

•Is clinically judged by the investigator to be at serious risk for suicide

•Has a recent (within 6 months before screening) or current laboratory result (if available) indicating a clinically significant laboratory abnormality

•Has Electrocardiogram (ECG) abnormalities obtained at screening that, in the opinion of the investigator, are clinically significant with regard to the subject's participation in the study. Bazett's corrected QT [QTcB] interval must be evaluated and must not exceed >458 msec in males or >474 msec in females

•At screening, has alanine transaminase (ALT/SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values greater than or equal to 3 times the ULN, or total bilirubin values greater than or equal to 2 times the ULN

•Has had IgG therapy (sometimes called gamma globulin therapy) within the last year or previous participation in any other study investigating active immunization against Aβ

•Requires treatment with other monoclonal antibodies

Endpoints (4)

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

Amyloid biomarkers

Other (unclassified)

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Mean change in plasma levels of Aβ1-42 after solanezumab infusion

Time frame:Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose

change from baseline, improvement

Secondary/protocol endpoint

Mean change in plasma levels of Aβ1-40 species after solanezumab infusion

Time frame:Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose

change from baseline, improvement

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3)

Time frame:Baseline up to 112 days post drug administration

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change in plasma levels of modified Aβ species after solanezumab infusion

Time frame:Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.