LY3954068 for Alzheimer's Disease

Phase 1

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 24 and week 72 (for optional bridging period participants)

Summary

This trial is evaluating the safety and effectiveness of a drug called LY3954068 in individuals with early symptomatic Alzheimer's Disease. The study involves two parts, A and B, with Part B being

Who is the study for?

This trial is for people with early symptomatic Alzheimer's Disease. Participants will receive a single dose of LY3954068 or placebo directly into the spinal fluid. Those in Part A may join an optional part B or bridging period to another study.

What is being tested?

The safety and blood levels of LY3954068 are being tested, along with its effects on Alzheimer's markers. The trial has two parts: Part A (single dose) and Part B (two doses), plus an optional extension into a related study.

What are the potential side effects?

Specific side effects aren't listed, but they could include typical reactions to drugs administered into the spinal fluid such as headache, back pain, nausea, or fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 24 and week 72 (for optional bridging period participants)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 24 and week 72 (for optional bridging period participants)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 24 and week 72 (for optional bridging period participants) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 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

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

Secondary study objectives

Optional Part B: PD: Change from Baseline of CSF tau

Optional Part B: PK: AUC

Optional Part B: PK: CSF concentration of LY3954068

+5 more