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Monoclonal Antibodies

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)
Awards & highlights

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 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

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3954068 (Part A)Experimental Treatment2 Interventions
Single ascending dose of LY3954068 administered intrathecally (IT)
Group II: LY3954068 (Optional Part B)Experimental Treatment2 Interventions
Multiple ascending dose of LY3954068 administered IT
Group III: Placebo (Optional Part B)Placebo Group2 Interventions
Multiple ascending dose of placebo administered IT
Group IV: Placebo (Part A)Placebo Group2 Interventions
Single ascending dose of placebo administered IT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flortaucipir F18
2013
Completed Phase 3
~1420

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,612 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
418,058 Total Patients Enrolled
~21 spots leftby Feb 2027
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