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

Alzheimer Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT06297590
• Study type: Interventional
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov@Lilly.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Completion date: February 2027