LY4560736 for Alzheimer's Disease

Not yet recruiting at 17 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new drug, LY4560736, to assess its safety and behavior in the body, focusing on Alzheimer's disease. It includes two groups: healthy participants and those with Alzheimer's. The trial will evaluate how the drug enters and affects the brain and measure a specific Alzheimer's-related protein. This trial may suit individuals with Alzheimer's who are of Japanese or Chinese descent and are not experiencing active infections or taking certain antibody treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that LY4560736 is likely to be safe for humans?

Research has shown that LY4560736 is a new treatment under testing for Alzheimer's disease. This study is in its early stages, focusing on the treatment's safety and tolerability. Since LY4560736 is being tested in humans for the first time, limited safety information is available.

In early trials like this, researchers monitor how the body reacts to the treatment and identify any side effects. Participants receive close observation for any negative reactions. If similar treatments had been found unsafe in past studies, they would not reach this stage. While specific safety data for LY4560736 is not yet available, testing it in humans indicates it has passed some initial safety checks. However, participants should understand that early clinical trials involve certain risks.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard Alzheimer's treatments, which often focus on managing symptoms using cholinesterase inhibitors or NMDA receptor antagonists, LY4560736 offers a fresh approach. Researchers are excited about LY4560736 because it could potentially address the underlying disease mechanisms by targeting amyloid deposits, a key feature of Alzheimer's. This treatment stands out due to its novel delivery methods—administered either intravenously or subcutaneously—and its use of advanced imaging techniques like amyloid PET scans to assess its effects. These unique features could pave the way for a more precise and effective treatment option for Alzheimer's patients.

What evidence suggests that LY4560736 could be an effective treatment for Alzheimer's Disease?

Research has shown that LY4560736 might help treat Alzheimer's disease by targeting amyloid plaques in the brain. These plaques, clumps of protein, often appear in the brains of people with Alzheimer's. Early studies suggest that treatments like LY4560736 can reduce these plaques, as observed in PET scans, a type of brain imaging. In this trial, participants will receive either LY4560736 or a placebo to evaluate its effectiveness. Although researchers are still studying LY4560736, other similar treatments have shown promise in slowing the disease. By lowering amyloid levels, LY4560736 might improve memory and thinking skills in people with Alzheimer's.678910

Who Is on the Research Team?

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults and people diagnosed with Alzheimer's disease. Participants must be able to stay at the research center as required, and Japanese (and possibly Chinese) individuals may be included. People with certain health issues or who can't safely participate will not be eligible.

Inclusion Criteria

Participants must meet eligibility criteria in the A1D-MC-ATMP screening protocol before entry into the treatment study
To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan
To qualify as Chinese for this study, all four of the participant's biological grandparents must be of exclusive Chinese descent and born in China

Exclusion Criteria

I have or have had tuberculosis (TB).
I have a current or recent active infection.
I am currently receiving or will soon start treatment with therapeutic antibodies.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-Ascending Dose (SAD) Treatment

LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers

Up to 13 weeks
At least 4 days stay in Clinical Research Unit (CRU)

Multiple Ascending Dose (MAD) Treatment

LY4560736 administered IV to participants with Alzheimer's Disease, including amyloid PET scan

Up to 13 weeks
Two stays in CRU, each lasting 1 to 2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4560736

Trial Overview

The study tests a new drug called LY4560736 compared to a placebo in both healthy volunteers and those with Alzheimer's disease. It also uses brain scans (Florbetapir F18 or Florbetaben F18) to measure Alzheimer’s-related proteins. The main focus is on safety and how the drug moves through the body.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4560736 Part B: Multiple Ascending Dose (MAD)Experimental Treatment3 Interventions
Group II: LY4560736 Part A: Single-Ascending Dose (SAD)Experimental Treatment1 Intervention
Group III: Placebo Part APlacebo Group1 Intervention
Group IV: Placebo Part BPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

J Prev Alz Dis 2026;2(13)

... ALZHEIMER'S DISEASE DEMENTIA: RESULTS FROM A PHASE 2 RANDOMIZED CLINICAL TRIAL ... ALZHEIMER'S DISEASE (STOMP-AD): A PILOT CLINICAL TRIAL, J Prev Alz Dis 2022;1 ...

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