A Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of LY4006895 in Healthy Volunteers and Patients With Early Symptomatic AD
Eli Lilly and Company
Summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD). Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.
Eligibility
- Age range
- 45–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for Part A and Part B: \- Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²) For Part A: * Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study For Part B: * Have early symptomatic AD, as defined by: * Gradual and progressive change in memory function for at least 6 months, as reported by the participant or informant * A Mini-Mental State Exam (MMSE) score of 18 to 30 at screening * A Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 (inclusive), with a memory box score gre…
Interventions
- DrugLY4006895
Administered IV
- DrugPlacebo
Administered IV
Locations (9)
- Collaborative Neuroscience Network - CNSLos Alamitos, California
- K2 Medical Research - The VillagesLady Lake, Florida
- K2 Medical ResearchMaitland, Florida
- Atlanta Center of Medical ResearchAtlanta, Georgia
- CenExel iResearch, LLC (CenExel iRA)Decatur, Georgia
- CenExel-HRIMarlton, New Jersey