ClinicaliQ Trial Snapshot
- A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer’s Disease — Recruiting • Phase I • Cardiology / Cardiovascular • NCT06297590.
- 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….
- Sponsor: Eli Lilly and Company.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * Have a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m²), inclusive, at screening. * Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant. * Have a mini mental state examination (MMSE) score of 18 to 30 at screening. * Have a clinical dementia rating (CDR) global score of 0.5 to 1.0, with a memory box score ≥ 0.5 at screening. * Meet flortaucipir F18 positron emission tomography (PET) criteria, as defined in the TAUVID™ FDA label (TAUVID™ prescribing information, 2024), demonstrating evidence of tau pathology. * Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP). * Participants must have up to 2 study partners who are with contact with the participant at least 10 hours per week and one of whom can attend study appointments.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.