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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
48
Administered IT
Administered IT
Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan
K2 Medical Research, LLC
Maitland, Florida, United States
RECRUITINGCharter Research, LLC
The Villages, Florida, United States
RECRUITINGCenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, United States
RECRUITINGMassachusetts General Hospital (MGH)
Charlestown, Massachusetts, United States
NOT_YET_RECRUITINGCenExel AMRI
Toms River, New Jersey, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGThe University of Tokyo Hospital
Bunkyō City, Japan
RECRUITINGNational Hospital for Neurology and Neurosurgery (UCLH)
London, United Kingdom
RECRUITINGRoyal Hallamshire Hospital
Sheffield, United Kingdom
RECRUITINGUniversity Hospital Southampton
Southampton, United Kingdom
RECRUITINGPart 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
A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Time frame: Baseline up to Week 24 and Week 72 (for optional bridging period participants)
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
A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Time frame: Baseline up to Week 52
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
To evaluate plasma concentration of LY3954068
Time frame: Day 1 up to Week 24
Part B: PK: Cmax
To evaluate plasma concentration of LY3954068
Time frame: Day -1 up to Week 52
Part A: PK: Area Under the Concentration Versus Time Curve (AUC)
To evaluate plasma concentration of LY3954068
Time frame: Day 1 up to Week 24
Part B: PK: AUC
To evaluate plasma concentration of LY3954068
Time frame: Day -1 up to Week 52
Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068
To evaluate CSF concentration of LY3954068
Time frame: Day 3 up to Week 24
Part B: PK: CSF concentration of LY3954068
To evaluate CSF concentration of LY3954068
Time frame: Day 3 up to Week 52
Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau
To evaluate the effect of LY3954068 on CSF tau
Time frame: Baseline up to Week 24
Part B: PD: Change from Baseline of CSF tau
To evaluate the effect of LY3954068 on CSF tau
Time frame: Baseline up to Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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