Active not recruitingPHASE3INTERVENTIONAL

A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)

The TRAILRUNNER-ALZ 3 study is investigating a new medication called Remternetug for individuals with early Alzheimer's disease. Its main goal is to find out if this drug can help delay or prevent the worsening of memory, thinking, and daily function issues that happen with Alzheimer's. Some participants will receive the active study drug, while others will get a placebo (an inactive substance). Researchers will compare these groups to understand the drug's effects. The study includes a screening phase, a period where participants receive treatments without knowing if it's the drug or placebo, and a follow-up observation period. Some participants who initially received the placebo might have the option to receive Remternetug later on. This research is crucial for finding new ways to manage Alzheimer's disease.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,400

Start

24 Oct 2024

Estimated completion

01 Oct 2030

Alzheimer's Disease

What is this study about?

This study, known as TRAILRUNNER-ALZ 3, is designed to investigate a new medication called Remternetug for people who are in the early stages of Alzheimer's disease. Alzheimer's is a condition that affects memory, thinking skills, and the ability to carry out everyday tasks. The main aim of this research is to see if Remternetug can help slow down the progression of these problems compared to a placebo, which is an inactive substance that looks just like the study drug but doesn't contain any medicine.

Researchers will carefully monitor participants to see if there's a difference in how quickly their symptoms develop or get worse. Finding new treatments that can slow down Alzheimer's is very important, as it could significantly improve the quality of life for many people and their families. This study is a crucial step in understanding if Remternetug could be a useful new treatment option in the future.

Participation in the study involves several phases. Initially, there's a screening period to make sure it's safe and appropriate for you to join. Then, there's a treatment period where you'll receive either Remternetug or the placebo, and neither you nor your doctor will know which one you're getting. Following this, there's an observation period. Importantly, if you receive the placebo during the main treatment phase, you might have the opportunity to extend your participation and receive Remternetug afterwards. The entire study could last several years, highlighting the thoroughness required for this type of research.

Key takeaways

The study tests a new drug, Remternetug, for early Alzheimer's.
It aims to see if the drug can slow memory and thinking decline.
Participation could last up to 5 years, with regular medical checks.
Some participants will receive a placebo; others may later get the active drug.
You must have a reliable 'study partner' for the research.
You can stop participating at any time you wish.

Who may be eligible?

To be considered for this study, you would generally need to be between 55 and 80 years old and have been diagnosed with early Alzheimer's disease. A key requirement is having a test result that shows a specific change in your brain (called phosphorylated tau) which is linked to Alzheimer's protein deposits. You would also need someone close to you, like a family member or friend, who can reliably share information about your daily life and memory habits, as well as a backup person.

Researchers will also check your memory, thinking, and daily function abilities through specific tests, making sure these are only mildly affected. If you're already taking medication for Alzheimer's symptoms, the dose should have been stable for at least 30 days before the study starts. You'll also need to be able to read, see, and hear well enough to complete all the study tests.

There are also some reasons why you might not be able to join. These include having other serious conditions that could affect your brain or your participation, such as certain cancers with a high risk of coming back, severe allergies, or other significant health problems found during medical checks. If you've had certain types of previous treatments for Alzheimer's or if an MRI scan of your brain doesn't meet the study's requirements, you would also be unable to take part.

Quick self-check

Are you between 55 and 80 years old?
Do you have early Alzheimer's disease?
Do you have someone who can be your 'study partner'?
Do you have only mild memory and thinking problems?
Have you had stable Alzheimer's medication (if any) for at least 30 days?
Are you generally in good health otherwise?

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, it could last for up to 255 weeks, which is about five years. It starts with a 'screening' phase to check if the study is right for you. If you qualify, you'll then enter a 'double-blind treatment period'. This means that for a while, you'll receive either the study drug (Remternetug) or a placebo (an inactive substance), and neither you nor your study doctor will know which one you're getting. This is done to ensure the results are as fair and unbiased as possible.

During this time, you'll have regular visits to the clinic for various assessments, which might include memory and thinking tests, blood tests, and MRI scans. Following the treatment period, there will be a 'double-blind observation period' where you'll continue to be monitored. Towards the end of the study, if you were in the group that received the placebo during the main treatment phase, you might have the option to continue in an 'open-label extension period', where everyone receives Remternetug. You'll be given detailed information about all visits, tests, and procedures before you make any decision to participate.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as contributing to scientific research and potentially receiving a new investigational treatment that is not yet widely available. However, there's no guarantee that the study drug will be effective for you, and you might receive a placebo. Like all medicines, Remternetug could have side effects, which the study team will monitor closely. You will be fully informed of any known risks before you decide to participate. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (262)

Parkway Medical Center
Birmingham, United States
MD First Research - Chandler
Chandler, United States
Care Access - 801 South Power Road, Mesa
Mesa, United States
Banner Alzheimer's Institute
Phoenix, United States
Banner Alzheimer's Institute Tucson
Tucson, United States
Neuro-Pain Medical Center
Fresno, United States
Care Access - Huntington Beach
Huntington Beach, United States
Inglewood Clinical
Inglewood, United States
Irvine Clinical Research
Irvine, United States
Healthy Brain Clinic
Long Beach, United States
Riverside Clinical
Riverside, United States
Clinical Trials Research
Sacramento, United States

+250 more sites — see the official record for the full list.

Common questions

What is Remternetug?

Remternetug is a new medicine being studied for early Alzheimer's disease. Researchers want to see if it can help slow down the worsening of memory and thinking problems.

What does 'double-blind' mean?

Double-blind means that during part of the study, neither you nor your doctor will know if you are receiving the active study drug or a placebo (an inactive substance). This helps ensure the study results are fair.

What is a placebo?

A placebo is an inactive substance that looks exactly like the study drug but doesn't contain any medicine. It's used to compare against the active drug to see if the drug is truly effective.

How long would I need to participate?

Participation could last for up to 255 weeks, which is about five years, including screening, treatment, and observation periods. Some might have an option to continue longer.

Can I leave the study at any time?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any point, for any reason, without it affecting your usual medical care.