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Clinical Trials List

Protocol NumberH8A-MC-LZAO

2010-05-01 - 2014-07-31

Phase III

Terminated6

ICD-10G30.0

Alzheimer's disease with early onset

ICD-10G30.1

Alzheimer's disease with late onset

ICD-10G30.8

Other Alzheimer's disease

ICD-10G30.9

Alzheimer's disease, unspecified

ICD-9331.0

Alzheimer's disease

Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients with Alzheimer’s Disease.

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Jong-Ling Fuh Division of Neurology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chin-Chang Huang Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chung-Hsiang Liu Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 張瓊之 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 周志和 Division of Neurology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ching-Kuan Liu Division of Neurology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

CRO

Condition/Disease

Alzheimer's disease

Objectives

The main purpose of this trial is to analyze adverse events (AEs), vital signs, and vital signs after completing 18 months of solanezumab or placebo treatment in a double-blind registration trial (LZAM or LZAN) in Alzheimer’s disease (AD) patients. Laboratory evaluations, electrocardiograms (ECGs) and magnetic resonance imaging (MRIs) results evaluated the safety of solanezumab 24 months of open treatment.

Test Drug

Solanezumab

Active Ingredient

LY2062430

Dosage Form

IV drip

Dosage

20 mg

Endpoints

Efficacy/health results: Alzheimer's Disease Assessment Scale-Cognitive Score (ADAS-Cog), Alzheimer's Disease Cooperative Trial-Activity of Daily Living Scale (ADCS-ADL); Clinical Dementia Scale (CDR) ); Neuropsychiatric Inventory (NPI); Dementia Resource Utilization-Simple Scale (RUD-Lite); Alzheimer's Quality of Life Scale (QoL-AD) Patient Version and Agent Version; EuroQol Five Aspects Proxy version of Health-related Quality of Life Scale (EQ-5D Proxy) and Simple Intelligent Assessment Results (MMSE).

Safety: The safety assessment will include routine physical and neurological examinations, vital signs, weight, body temperature, 12-lead electrocardiogram (ECG) and laboratory assessments. This phase 3, open-label trial of solanezumab will also use scheduled magnetic resonance imaging (MRI) to evaluate microbleeds and subclinical cerebral edema, as well as the effects of hamster amyloid β (Aβ) and human amyloid β. (Aβ) or solanezumab's immunogenicity.

Biological analysis: The tested enzyme-linked immunosorbent assay (ELISA) method will be used to determine plasma solanezumab, amyloid β (Aβ) 1-40 and amyloid β (Aβ) 1-42 from processed blood samples. Concentration and titer of anti-solanezumab, anti-rodent amyloid β (Aβ) and anti-human amyloid β (Aβ).

Pharmacokinetics: Concentration data of solanezumab obtained from subgroup 1 of patients will be compiled and the concentration range will be reported.

Inclution Criteria

Participants were male and female patients with Alzheimer's disease (AD) who were 55 years of age or older and had completed any tandem test.

Exclusion Criteria

1. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
2. Are Eli Lilly and Company (Lilly) employees.
3. 3. Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
4. Meets feeder study discontinuation criteria at the last visit of the feeder study (Study LZAO Visit 1).

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    1300 participants

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