Preclinical AD
Conditions
Interventions
investigational material(s)
Generic name etc : Solanezumab
INN of investigational material : Solanezumab
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Admini
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MMSE score at screening of 25 to 30 global CDR score at screening of 0 Logical Memory II score at screening of 6 to 18 Florbetapir PET scan that shows evidence of brain amyloid pathology Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)
Exclusion criteria
Exclusion criteria: -Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline -Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded -Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study -Has had 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 -Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment -Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis) -Is clinically judged by the investigator to be at serious risk for suicide -Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) -Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory Change from Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) [ Time Frame: Baseline, Week 240; Baseline, Week 336 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory 1.Change from Baseline in Cognitive Function Index (CFI) [ Time Frame: Baseline, Week 240; Baseline, Week 336 ] 2.Change from Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score [ Time Frame: Baseline, Week 240; Baseline, Week 336 ] 3.Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr) [ Time Frame: Baseline, Week 240 ] 4.Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers [ Time Frame: Baseline, Week 240 ] 5.Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta) [ Time Frame: Baseline, Week 240 ] 6.Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 240 ] 7.Change from Baseline on the Clinical Dementia Rating-Sum of Boxes score (CDR-SB) [ Time Frame: Baseline, Week 336 ] 8.Change from Baseline on the Computerized Cognitive Composite (C3) [ Time Frame: Baseline, Week 336 ] | — |
Countries
Japan, North America, Oceania
Outcome results
None listed