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CompletedPhase 2

Solanezumab Safety Study in Japanese Patients With Alzheimer's Disease

Multiple-Dose Safety in Japanese Subjects With Mild-to-Moderate Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Solanezumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 15-26•MRI contraindications excluded

Primary endpoint

•Adverse events

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 ID12025

Secondary IDH8A-JE-LZAKEli Lilly and Company

NCT IDNCT00749216

Timeline

Milestones

Study start2008-09 (month precision)

Study first posted2008-09-09estimated

Primary completion2009-07actual (month precision)

Study completion2009-07actual (month precision)

Last update posted2010-06-02estimated

Assets

Drug assets

Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men or non-fertile women, at least 50 years of age.(Women who are not surgically sterilized must be post-menopausal for at least 1 year.)

•Patients with mild to moderate AD by following disease diagnostic criteria

-National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria

-Modified Hachinski Ischemia Scale score of ≦ 4

-Folstein Mini-Mental State Examination (MMSE) score of 15 through 26

-Geriatric Depression Scale (GDS) score of ≦ 10 on the staff-administered short form

Exclusion criteria

•Patients who don't have a reliable caregiver who is in frequent contact with the patient, who will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications.

•Patients who have an MRI or CT scan since the onset of symptoms of AD that is inconsistent with a diagnosis of AD.

•Patients who have received acetylcholinesterase inhibitors (AChEIs) or memantine for less than 4 months, or have less than 2 months of stable therapy on these treatments.

•Patients who have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator or subinvestigator(s)'s opinion, could interfere with the analyses of safety and efficacy in this study.

•Patients who have 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 within the last 5 years, or multiple episodes of head trauma.

•Patients who have 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 PSA post-resection.

•Patients who have allergies to humanized monoclonal antibodies.

•Patients who have ECG abnormalities obtained that, in the opinion of the investigator, are clinically significant with regard to the subject's participation in the study, including QTc prolongation (Bazett's corrected QTc interval, QTcB; males >435 msec or females >455 msec) or abnormally wide QRS complexes (resulting from bundle-branch blocks, interventricular conduction delays, or pacemakers).

•Patients who have a current, required use or expected use of excluded drugs through the duration(These drugs include typical neuroleptics (antipsychotics). In addition, typical neuroleptics may not be taken within 4 weeks.

•Patients who are currently taking chronic medications that affect central nervous system (CNS) function, and are not dose-stabilized for at least 4 weeks.

•Patients who have a ventriculoperitoneal shunt or gamma globulin (IgG) therapy within the last year.

•Patients who have previously completed or withdrawn from this study or previous participation in any other study investigating active immunization against Aβ.

•Patients who have any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.

•Patients who weigh less than 40 kg.

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

Safety / tolerability / PK

Global cognition

Amyloid biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

Changes in the extended ADAS-Cog stand for Alzheimer's Disease Assessment Scale-Cognitive subscale

Time frame:6 months

ADAS-Cog

descriptive

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

pharmacodynamic of Aβ1-40 and Aβ1-42

Time frame:6 months

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Adverse events

Time frame:6 months

event count, event

Secondary/protocol endpoint

Pharmacokinetics

Time frame:6 months

descriptive

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.