Alzheimer's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : LY3303560
INN of investigational material : zagotenemab
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administ
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must have gradual and progressive change in memory function for >6 months. - Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.
Exclusion criteria
Exclusion criteria: - Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study. - Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy <24 months. - Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread. - Participants must not have serious risk for suicide. - Participants must not have history of drug or alcohol use disorder within the last 2 years. - Participants must not have multiple severe drug allergies - Participants must not have HIV, Hepatitis B or Hepatitis C - Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline on the iADRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Change from Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, 104 weeks ] - Change from Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score [ Time Frame: Baseline, 104 weeks ] - Change from Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, 104 weeks ] - Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 104 weeks ] - Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 104 weeks ] - Change from Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 104 weeks ] - Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through Week 104 ] - Number of Participants with Treatment Emergent Anti-LY3303560 Antibodies [ Time Frame: Baseline through Week 113 ] | — |
Countries
Japan, North America
Outcome results
None listed