A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Start Date
8/15/2024
Completion Date
2/1/2027
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. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.
Eligibility Criteria
Age Range: 50 years to 85 years
Interventions
LY3954068
Placebo
Flortaucipir F18
Conditions
Locations
K2 Medical Research, LLC
Maitland, Florida 32751
United States
Charter Research, LLC
The Villages, Florida 32162
United States
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia 30030
United States
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts 02129
United States
CenExel AMRI
Toms River, New Jersey 08755
United States
Duke University
Durham, North Carolina 27710
United States
The University of Tokyo Hospital
Bunkyō City, 113-8655
Japan
National Hospital for Neurology and Neurosurgery (UCLH)
London, WC1N 3BG
United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF
United Kingdom
University Hospital Southampton
Southampton, SO16 6YD
United Kingdom