RecruitingPHASE1INTERVENTIONAL

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

This research study is about a new drug, LY3954068, for people in the early stages of Alzheimer's disease. The main goals are to check if the new drug is safe, to understand how much of it gets into the body and how it works, and to see if it changes certain signs of Alzheimer's. The study involves two parts. In the first part, some people will get a single dose of LY3954068 or a dummy treatment (placebo) injected into their spinal fluid. In the second part, others will get two doses of either the drug or placebo, also in the spinal fluid. There might also be a chance to continue with the drug in a separate study afterwards. The study could last up to 45 weeks for some participants and up to 100 weeks for others.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

Start

15 Aug 2024

Estimated completion

01 Feb 2027

Alzheimer Disease

What is this study about?

This study is a very early investigation into a new potential medicine named LY3954068, which is being tested in people who have early symptoms of Alzheimer's disease. When we say 'early symptoms', we mean people who are just starting to experience memory changes and other signs.

The main aim of this research is to check how safe this new medicine is for people to take. Researchers also want to find out how the medicine behaves in the body – for example, how much of it reaches the bloodstream and how long it stays there. They will also look to see if the medicine has any effect on things in the body that are linked to Alzheimer’s disease. This is a common first step for any new medicine to make sure it's safe before it can be studied further.

The study is divided into two parts. In Part A, some volunteers will receive a single dose of LY3954068 or a placebo (a substance with no active drug). In Part B, other volunteers will receive two doses of either the medicine or the placebo. This medicine will be given as an injection directly into the fluid around the spinal cord. This type of study is crucial for learning about new treatments that might help people in the future.

Key takeaways

Tests a new medicine (LY3954068) for early Alzheimer's disease.
Main goal is to check safety and how the medicine works in the body.
Medicine is given directly into the spinal fluid.
You might receive the active medicine or a dummy treatment (placebo).
Study duration ranges from about 45 to 100 weeks.
Your health and memory will be closely monitored with regular check-ups and scans.

Who may be eligible?

To be considered for this study, you would generally need to be between 50 and 85 years old. You should have noticed your memory changing slowly over at least 6 months. Doctors will also check your memory and thinking skills using specific tests, and they will look for signs of Alzheimer's in your brain using special scans.

There are also some things that would mean you couldn't join the study. For example, if you have other serious health problems like heart, kidney, or liver disease, or if you have certain back problems. You also wouldn't be able to join if you've had a bad reaction to certain dyes used in scans, or if you can't have an MRI scan due to metal in your body or claustrophobia. If you've recently taken certain other Alzheimer's drugs, or if you've previously had similar types of injections into your spinal fluid for research, you might not be eligible.

Additionally, you would need to have two close friends or family members who spend at least 10 hours a week with you. One of these people would need to be able to come to your study appointments with you, as they can provide important information to the researchers.

Quick self-check

Are you between 50 and 85 years old?
Have you noticed your memory slowly changing for at least 6 months?
Do you have a close friend or family member who sees you often and could attend appointments?
Do you feel generally well and don't have other serious ongoing health issues?
Are you comfortable with MRI scans and don't have metal implants that prevent them?
Have you not recently taken certain other Alzheimer's research drugs?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first go through a screening period where doctors run tests to see if the study is right for you. If you qualify, you'll be assigned to either Part A or Part B of the study. In Part A, you'll receive a single injection into your spinal fluid, which will be either the study medicine or a placebo. In Part B, you'll receive two of these injections. You won't know whether you're getting the active medicine or the placebo until after the study is over.

Throughout the study, you'll have several visits to the clinic for various tests and assessments. These will include blood tests, memory tests, and brain scans to see how you're doing and how the medicine might be affecting you. Researchers will also be checking your general health very carefully. The total time you'd be involved in the study could be around 45 weeks for Part A, or up to 100 weeks for Part B. After your main study period, you might have the chance to join another study where you could continue receiving the active medicine.

Potential risks and benefits

Taking part in a research study like this could potentially help future generations by providing valuable information about new ways to treat Alzheimer's disease. However, there's no guarantee the medicine will help you personally. Like all medicines, LY3954068 might have side effects, especially since it's an early-stage study where not everything is known. Injections into the spinal fluid can also have their own small risks, such as headache or discomfort. All participants have the right to withdraw from the study at any time, for any reason, without it affecting their usual medical care.

Locations (10)

K2 Medical Research, LLC
Maitland, United States· Recruiting
Charter Research, LLC
The Villages, United States· Recruiting
CenExel iResearch, LLC (CenExel iRA)
Decatur, United States· Recruiting
Massachusetts General Hospital (MGH)
Charlestown, United States· Not yet recruiting
CenExel AMRI
Toms River, United States· Recruiting
Duke University
Durham, United States· Recruiting
The University of Tokyo Hospital
Bunkyō City, Japan· Recruiting
National Hospital for Neurology and Neurosurgery (UCLH)
London, United Kingdom· Recruiting
Royal Hallamshire Hospital
Sheffield, United Kingdom· Not yet recruiting
University Hospital Southampton
Southampton, United Kingdom· Not yet recruiting

Common questions

What is LY3954068?

It's a new medicine being tested to see if it can help people with early Alzheimer's disease. This is a very early stage of research.

How will the medicine be given?

It will be given as an injection directly into the fluid that surrounds your spinal cord.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. This helps researchers fairly compare its effects.

How long does the study last?

The study could last between 45 weeks and 100 weeks, depending on which part you join, and includes checks before and after treatment.

Will I know if I'm getting the active medicine or the placebo?

No, you won't know during the study which treatment you are receiving. This is common in research to ensure fair results.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.