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EXPEDITION2

CompletedPhase 3

Effect of LY2062430 on the Progression of Alzheimer's Disease

Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

Asset

Solanezumab

Listed sites

95

Recruiting sites

-

Enrollment

1,040

actual

Study population

Alzheimer’s disease

Key I/E criteria

mild-to-moderate ADMMSE 16-26MRI 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 ID11934
Secondary IDH8A-MC-LZANEli Lilly and Company
NCT IDNCT00904683

Timeline

Milestones

Study start2009-05 (month precision)
Study first posted2009-05-20estimated
Primary completion2012-06actual (month precision)
Study completion2012-06actual (month precision)
Last update posted2012-12-13estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization

Exclusion criteria

Has serious or unstable illness(es)
Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
Has allergies to humanized monoclonal antibodies
Chronic alcohol and/or drug abuse within the past 5 years
Has any contraindications for MRI studies
Requires treatment with another monoclonal antibody

Endpoints (11)

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

Caregiver / quality of life
3
Global cognition
2
Other (unclassified)
2
Function / daily living
1
Behavior / neuropsychiatric
1
Amyloid biomarkers
1
Neuroimaging
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:Baseline, Week 80

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

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score

Time frame:Baseline, Week 80

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score

Time frame:Baseline, Week 80

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, Week 80

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline to Week 80 in Plasma Amyloid Beta Levels

Time frame:Baseline, Week 80

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 80

change from baseline, improvement

Caregiver / quality of life

3 endpoints
Secondary/protocol endpoint

Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score

Time frame:Baseline, Week 80

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item and 12-Item Scale (ADAS-Cog11 and ADAS-Cog12)

Time frame:Baseline, Week 80

ADAS-Cog

change from baseline, improvement

Publications (7)

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 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.