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Study on JNJ-64042056 for Preclinical Alzheimer's Disease in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Preclinical Alzheimer's Disease, a stage of Alzheimer's where symptoms are not yet noticeable but changes in the brain have begun. The study will evaluate a treatment called JNJ-64042056, which is a type of active immunotherapy designed to target a protein in the brain known as phosphorylated tau. This protein is associated with the development of Alzheimer's Disease. The trial will compare the effects of JNJ-64042056 with a placebo to see if it can slow down cognitive decline, which refers to the gradual loss of memory and thinking skills.

Participants in the study will receive either the JNJ-64042056 treatment or a placebo through injections. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations. The study will take place over a period of time, with regular assessments to monitor the participants' cognitive abilities and overall health.

The main goal of the study is to determine if JNJ-64042056 can effectively slow down the progression of cognitive decline in individuals with Preclinical Alzheimer's Disease. By participating in this study, researchers hope to gather important information that could lead to new treatments for Alzheimer's Disease in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and cognitive assessments.
A brain scan will be conducted to check for elevated tau protein levels, which are associated with Alzheimer's disease.
Step 2
Randomization
After eligibility is confirmed, you will be randomly assigned to receive either the study medication, JNJ-64042056, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.
Step 3
Treatment administration
You will receive the assigned treatment as an injection. The study medication, JNJ-64042056, is administered as a dispersion for injection.
The frequency and dosage of the injections will be determined by the study protocol and communicated to you by the study team.
Step 4
Regular follow-up visits
You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include cognitive assessments and other evaluations to track any changes in your condition.
The primary goal is to assess changes in cognitive function over time, using a specific test called the Preclinical AD Cognitive Composite 5 (PACC-5).
Step 5
Final assessment
At the end of the study period, which is estimated to be in April 2031, a final assessment will be conducted. This will include a comprehensive evaluation of your cognitive function and overall health.
The results will help determine the effectiveness and safety of the study medication compared to the placebo.

Who can join the trial?

5 criteria

Age between 55 and 75 years old at the time of joining the study.
Have elevated brain tau pathology, which means having a specific level of a protein called tau in the brain, as shown by a special brain scan called a tau PET scan.
Have a CDR global score of 0, which means no signs of dementia, at the start of the study.
Have a MMSE score of 27 or higher, which is a test that checks memory and thinking skills. This score may be adjusted based on education level.
Be able to read and write, with at least 5 years of formal education, as confirmed by both the participant and a study partner.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients with a history of severe allergic reactions to any medication.
Patients who are unable to comply with the study procedures.
Patients with a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients with a known psychiatric disorder that could interfere with the study.
Patients who have been diagnosed with any form of dementia other than **Alzheimer's Disease**.
Patients who have a significant neurological disorder other than **Alzheimer's Disease**.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Bonn, Germany
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

JNJ-64042056 is a type of treatment designed to help people with early signs of Alzheimer's disease. It works by targeting a specific protein in the brain called tau, which is thought to play a role in the development of Alzheimer's. This treatment aims to slow down the decline in memory and thinking skills that can happen in people with this condition. The goal is to see if this treatment can help maintain cognitive abilities, which are important for daily activities and quality of life.

What is already known about the treatment

JNJ-64042056 – JNJ-64042056 is an investigational medication administered as an injection, designed to target phosphorylated tau proteins in the brain, which are associated with Alzheimer's disease. Currently, it is being studied in clinical trials and is not yet approved for general medical use. The main therapeutic indication for JNJ-64042056 is preclinical Alzheimer's disease, aiming to slow cognitive decline before significant symptoms appear. It works by stimulating the immune system to recognize and attack abnormal tau proteins, potentially preventing or delaying the progression of Alzheimer's disease. This medication falls under the pharmacological classification of active immunotherapy.

Investigated diseases

Preclinical Alzheimer’s Disease – Preclinical Alzheimer's Disease is an early stage of Alzheimer's where individuals show no noticeable symptoms of cognitive decline, but biological changes associated with the disease are present in the brain. During this stage, amyloid plaques and tau tangles may begin to form, which are hallmark features of Alzheimer's pathology. The disease progresses silently, with these changes occurring years or even decades before any clinical symptoms appear. As the disease advances, it may eventually lead to mild cognitive impairment and, later, to more pronounced symptoms of Alzheimer's Disease. This stage is crucial for research as it offers a window for potential interventions before significant cognitive decline occurs.