Active not recruitingPHASE2INTERVENTIONAL

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

This research study is looking into a new experimental medicine, JNJ-64042056, for people who have very early signs of Alzheimer's disease, even before they experience memory problems. The main goal is to understand if this medicine can help prevent a protein called tau from spreading and building up in the brain. Tau build-up is a key feature of Alzheimer's. Researchers will use special brain scans to measure how the medicine affects tau compared to a dummy medicine (placebo). By studying people aged 55 to 75 who show early brain changes but no memory issues, scientists hope to find ways to slow down or even stop the progression of Alzheimer's disease before it fully develops.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Pharmaceutica N.V., Belgium

Enrolment target

Start

22 Jul 2024

Estimated completion

22 Dec 2026

Alzheimer Disease

What is this study about?

This study is trying to understand if a new medicine, called JNJ-64042056, can help people who are at a very early stage of Alzheimer's disease. At this stage, people don't usually have any noticeable memory problems, but special brain scans might show early changes happening in their brain.

One of the key changes in Alzheimer's disease is the build-up and spread of a natural protein called tau. When tau builds up too much, it can harm brain cells. Researchers want to see if this new medicine can slow down or stop this tau build-up and spread. To do this, some people in the study will receive the new medicine, while others will receive a 'placebo', which looks like the medicine but has no active ingredients. This helps scientists compare the effects accurately.

The findings from this study are really important because they could lead to new ways of treating Alzheimer's disease much earlier, potentially even before symptoms start. By targeting these early brain changes, the hope is to prevent or significantly delay the progression of the condition.

Key takeaways

This study is testing an experimental medicine for very early Alzheimer's disease.
It aims to see if the medicine can stop a brain protein called tau from building up.
Participants will either receive the new medicine or a dummy medicine (placebo).
Special brain scans will be used to track changes in the tau protein.
The study focuses on people aged 55-75 who have early brain changes but no memory symptoms.
Participation involves regular clinic visits, tests, and brain scans.

Who may be eligible?

To join this study, people need to be between 55 and 75 years old and not be able to have children (if female). Participants must have high levels of a specific brain protein called tau, which will be checked with a special brain scan. You should also have excellent memory and thinking skills, scoring perfectly on a common memory test, and be able to read and write, with at least five years of education.

There are several reasons why someone *can't* join this study. This includes having a clearly diagnosed form of Alzheimer's disease or any other type of memory loss condition like Frontotemporal Dementia or Vascular Dementia. Also, if you've already been diagnosed with Mild Cognitive Impairment (MCI) or have certain other long-term brain conditions, you won't be able to participate. The study is very specific about ensuring participants are at a 'preclinical' stage, meaning they have the brain changes but not yet the symptoms.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 55 and 75 years old?
Do you currently have good memory and thinking skills, with no noticeable problems?
Can you read and write, with at least 5 years of schooling?
Have you *not* been diagnosed with Alzheimer's disease or any other type of dementia like Vascular Dementia or Mild Cognitive Impairment (MCI)?
Are you able to have a special brain scan called a tau PET scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either receive the new medicine (JNJ-64042056) or a dummy medicine (placebo). You won't know which one you're getting. You'll have regular visits to the study clinic, where doctors and nurses will monitor your health, perform memory and thinking tests, and take blood samples. You will also have special brain scans to check the tau protein levels in your brain. The study will involve giving you the medicine, and you'll have follow-up visits to see how you're doing. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained by the study team.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to scientific understanding and potentially receiving a new medicine that might help. However, as it's an experimental medicine, there could be unknown risks or side effects. The study team will explain all known risks to you before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (90)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Xenoscience Inc.
Verified postcode
Phoenix, United States
Irvine Clinical Research
Verified postcode
Irvine, United States
Esperanza Clinical
Verified postcode
Murrieta, United States
Artemis Institute for Clinical Research Riverside
Verified postcode
Riverside, United States
Artemis Institute for Clinical Research San Diego
Verified postcode
San Diego, United States
Yale University School Of Medicine
Verified postcode
New Haven, United States
JEM Research LLC
Verified postcode
Atlantis, United States
Excel Medical Clinical Trials, LLC
Verified postcode
Boca Raton, United States
K2 Medical Research Winter Garden
Verified postcode
Clermont, United States
Clinical NeuroScience Solutions Inc
Verified postcode
Jacksonville, United States
K2 Medical Research Lady Lake
Verified postcode
Lady Lake, United States
K2 Medical Research Maitland
Verified postcode
Maitland, United States

Common questions

What is 'preclinical Alzheimer's disease'?

This means you have early signs of Alzheimer's in your brain, like protein build-up, but you don't yet have any memory loss or other symptoms.

What is 'tau protein'?

Tau is a natural protein in your brain. In Alzheimer's, it can build up and spread, which is thought to damage brain cells.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the true effects of the new drug.

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

No, this is a 'blinded' study, meaning neither you nor the study team will know until after the study is over. This ensures the results are fair.

How will the doctors check the tau protein levels?

They will use a special type of brain scan called a 'tau PET scan' to look for and measure tau build-up in your brain.