RecruitingPhase IIInterventional

A study of JNJ-64042056 in participants with preclinical Alzheimer's disease

Alzheimer's disease causes changes in the brain many years before memory problems become obvious. This early stage is known as 'preclinical Alzheimer's'. In this study, researchers are testing an experimental treatment called JNJ-64042056 that acts like a vaccine. It helps your immune system produce natural defences to clear away tau, an abnormal protein that builds up and damages brain cells. The trial is open to adults aged 55 to 75 who show early signs of tau protein on brain scans but still have normal memory and thinking. Participants are chosen by chance to receive either the study medicine or a dummy jab (placebo) injected into an arm muscle over about four years. Doctors will carry out regular health checks, brain scans, and memory tests to find out if the treatment can safely delay or prevent the onset of Alzheimer's symptoms.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Janssen-Cilag International NV

Enrolment target

498

Start

28 May 2024

Estimated completion

02 Jul 2027

Preclinical Alzheimer’s Disease

What is this study about?

Alzheimer's disease is a brain condition that slowly harms memory, thinking, and daily independence. Scientists now know that the physical changes behind Alzheimer's actually start in the brain up to twenty years before any symptoms show up. This silent window of time is known as 'preclinical Alzheimer's disease'. During this stage, a protein called tau begins to tangle and build up inside brain cells, eventually causing them to stop working properly.

This study is testing an experimental medicine known as JNJ-64042056. It is a type of active immunotherapy, meaning it works rather like a vaccine. The medicine encourages your own immune system to make antibodies that target and clear away harmful tau proteins. Researchers hope that removing these proteins early on will protect brain cells and stop memory problems from developing in the first place.

Finding treatments that work at this silent stage could completely change how Alzheimer's is prevented in the future. By stepping in before brain cells are badly damaged, researchers hope to keep people healthy and independent for much longer. This trial will help doctors understand whether this approach is both safe and effective over several years.

Key takeaways

The trial tests an experimental injection aimed at clearing brain proteins linked to Alzheimer's disease.
It is for adults aged 55 to 75 who show early protein build-up on scans but have normal memory.
Participants are randomly assigned to receive either the trial medicine or a dummy jab (placebo).
Taking part lasts around four years and involves regular clinic appointments, memory tests, and brain scans.
Joining is completely voluntary, and your health will be monitored closely throughout.

Who may be eligible?

This study is designed for adults aged 55 to 75 who have early signs of tau protein build-up in their brain, but who do not have memory loss or dementia. To check this, doctors will use special brain scans and memory questionnaires. Participants must be able to read and write, have completed at least five years of education, and have a study partner (such as a spouse, relative, or close friend) who knows them well and can help answer questions.

You cannot take part if you already have noticeable memory problems, Mild Cognitive Impairment, or any type of diagnosed dementia (such as Alzheimer's, vascular, or Lewy body dementia). People with rare forms of inherited early-onset Alzheimer's that run strongly in their family are also excluded.

Additionally, you cannot join if you have other brain disorders, previous strokes, or serious medical conditions that could significantly affect your memory or make taking part unsafe. The study team will carry out health checks and brain scans to ensure you meet all safety requirements.

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.

I am between 55 and 75 years of age.
My memory and thinking skills are normal, and I do not have a diagnosis of dementia or memory impairment.
I can read and write, and I completed at least five years of formal education.
I have a family member or friend willing to attend appointments with me as my study partner.
I am comfortable receiving injections into my arm and attending regular clinic visits over a four-year period.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts around four years in total. Before starting, you will complete a screening period of up to 17 weeks. During this time, doctors will carry out health checks, blood and urine tests, heart tracings (ECGs), memory tests, and brain scans (MRI and PET) to make sure the trial is suitable for you.

If you join, you will be assigned by chance (like flipping a coin) to receive either the study drug (JNJ-64042056) or an inactive dummy injection (placebo). Neither you nor your study doctor will know which one you receive. The treatment is given as an injection into your upper arm muscle over roughly three and a half years (up to Week 180).

You will visit the clinic regularly throughout the study so the medical team can monitor your health, check for side effects, and track your thinking skills. Once the treatment period ends, there is a final two-week follow-up check to make sure you are feeling well.

Potential risks and benefits

There is no guarantee that taking part will directly improve your health, particularly if you receive the placebo, because this medicine is still being tested. However, your participation could provide vital answers that help protect future generations from Alzheimer's disease. As with any experimental drug, there is a risk of side effects. The most common side effects seen so far are mild reactions where the injection is given, such as redness, swelling, soreness, itching, or temporary firmness in the arm. Other rare or unexpected side effects are possible, but the medical team will watch your health very closely at every visit. Taking part is entirely voluntary, and you are free to leave the trial at any time without your standard medical care being affected.

Locations (9)

Rice - the Research Institute for the Care of Older People
City only
Bath, England
Re:Cognition Health
Unverified
- NO COUNTRY SPECIFIED, assuming England, England
Kings College Hospital
Approximate
London, England
Moorgreen Hospital
City only
Southampton, England
Charing Cross Hospital
Approximate
London, England
Warneford Hospital
Approximate
Oxford, England
Southampton
Unverified
Southampton, England
Southmead Hospital
Unverified
Bristol, England
Scottish Brain Sciences
Unverified
Edinburgh, Scotland

Common questions

What does 'preclinical' Alzheimer's mean?

It means early biological changes (such as protein build-up) have started in the brain, but your memory, thinking, and daily abilities remain completely normal.

Will I definitely receive the new medicine?

No. You have a 50% chance of receiving the trial medicine and a 50% chance of receiving a placebo (a dummy jab with no active drug), chosen at random by a computer.

Is this medicine a vaccine?

It works in a similar way to a vaccine by prompting your own immune system to make antibodies that target and clear away unwanted tau proteins in the brain.

Why do I need a study partner?

A study partner is a friend or family member who knows you well. They help the doctors by sharing independent observations about your everyday memory and general wellbeing.

Can I leave the study early if I change my mind?

Yes. Taking part is completely your choice. You can withdraw at any point, for any reason, without giving an explanation and without affecting your normal healthcare.

How to find out more

- Medical Information and Product Information Enquiry

JanssenUKRegistryQueries@its.jnj.com; medinfo@its.jnj.com - Official trial record

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