LY3954068 for Alzheimer's Disease

Recruiting at17 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: Amyloid therapies, Anti-tau therapies

Disqualifiers: Serious illnesses, MRI contraindications, others

Trial Summary

What is the purpose of this trial?

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 45 weeks for Part A, and, if conducted, 73 weeks for Part B, including the screening period. If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 96 weeks, including the screening period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on an amyloid targeted therapy (ATT) currently. If you have taken ATT in the past, it must have been more than a year ago, and this will be reviewed by the investigator.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant

Meet flortaucipir positron emission tomography (PET) criteria demonstrating evidence of tau pathology

Have a mini mental state examination (MMSE) score of 18 to 30 at screening

Exclusion Criteria

I do not have serious health issues that could affect the study or a life expectancy under 2 years.

Have a sensitivity to flortaucipir 18F

I have been treated with experimental drugs or anti-tau therapy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single dose of LY3954068 or placebo administered intrathecally

24 weeks

Multiple visits for monitoring and assessments

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment in Part A

21 weeks

Treatment Part B (Optional)

Participants receive 2 doses of LY3954068 or placebo administered intrathecally

52 weeks

Multiple visits for monitoring and assessments

Follow-up Part B (Optional)

Participants are monitored for safety and effectiveness after treatment in Part B

21 weeks

Optional Bridging Period

Participants may join an optional bridging period to a separate potential study

96 weeks

Treatment Details

Interventions

• LY3954068 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: LY3954068 (Part A) Experimental Treatment 2 Interventions

Single ascending dose of LY3954068 administered intrathecally (IT)

Group II: LY3954068 (Optional Part B) Experimental Treatment 2 Interventions

Multiple ascending dose of LY3954068 administered IT

Group III: Placebo (Optional Part B) Placebo Group 2 Interventions

Multiple ascending dose of placebo administered IT

Group IV: Placebo (Part A) Placebo Group 2 Interventions

Single ascending dose of placebo administered IT

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University