Clinical Research Directory
Browse clinical research sites, groups, and studies.
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Sponsor: Eli Lilly and Company
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.
Official title: A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3954068 in Patients With Early Symptomatic Alzheimer's Disease
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-08-15
Completion Date
2027-02
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
LY3954068
Administered IT
Placebo
Administered IT
Flortaucipir F18
Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan
Locations (10)
K2 Medical Research, LLC
Maitland, Florida, United States
Charter Research, LLC
The Villages, Florida, United States
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, United States
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts, United States
CenExel AMRI
Toms River, New Jersey, United States
Duke University
Durham, North Carolina, United States
The University of Tokyo Hospital
Bunkyō City, Japan
National Hospital for Neurology and Neurosurgery (UCLH)
London, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
University Hospital Southampton
Southampton, United Kingdom