A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease - Trial NCT06297590

Timeline & Enrollment

Primary Outcome

Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration,Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Summary

The main purpose of this study is to evaluate the safety of LY3954068 in participants with
 early symptomatic Alzheimer's Disease (AD). The study will also investigate how much
 LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.
 
 The study will be comprised of two parts, A and B. Part B is optional, and participants from
 Part A may also have the opportunity to join an optional bridging period to a separate
 potential study where participants would receive LY3954068. Each enrolled participant in Part
 A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal
 fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or
 placebo administered into the spinal fluid.
 
 The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for
 Part B. If conducted, the optional bridging period for Part A participants would last up to
 approximately 1 year after their completion of Part A.
 
 If the optional bridging period is conducted, participants in Part A could be enrolled in the
 separate potential study for up to approximately 120 weeks.

ICD-10 Classifications