A Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3954068 in Early Symptomatic Alzheimer's Disease

What this Trial Is About

Researchers are evaluating the safety of LY3954068 in people with early symptomatic Alzheimer's Disease. This study also examines how much of the drug enters the bloodstream and its effects on Alzheimer's markers. It is a Phase 1 trial sponsored by Eli Lilly and Company focused on participants aged 50 to 85 years with early signs of the disease. The study includes two parts: Part A and Part B. In Part A, each participant receives a single dose of LY3954068 or placebo injected into the spinal fluid. In Part B, participants receive two doses of either LY3954068 or placebo administered the same way. There is an optional bridging period after Part B where participants may receive LY3954068 in a separate study. Part A lasts about 45 weeks including screening, and Part B lasts about 100 weeks including screening. Participants will undergo regular assessments such as safety monitoring for adverse events related to the study drug, blood and spinal fluid sampling to measure drug levels and effects on tau proteins, and imaging with Flortaucipir F18 PET scans for tau pathology. Cognitive tests like the Mini Mental State Examination and Clinical Dementia Rating will be used. Safety and drug effects will be followed up to 24 weeks in Part A and up to 52 weeks in Part B, with additional monitoring during the bridging period if chosen.

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease