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Study on the Effects of JNJ-63733657 and Florquinitau F18 in Patients with Early Alzheimer's Disease

Fast replyInvestigationalNo placebo

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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 Early Alzheimer's Disease, a condition that affects memory and thinking skills. The study will evaluate a treatment called JNJ-63733657, which is an anti-tau monoclonal antibody. Monoclonal antibodies are special proteins made in a lab that can attach to specific substances in the body. In this case, the treatment targets tau, a protein that can form tangles in the brain of people with Alzheimer's Disease.

The purpose of the study is to assess the effectiveness and safety of JNJ-63733657 compared to a placebo. Participants will receive the treatment as a solution for infusion, which means it will be given through a vein. The study will follow a randomized, double-blind, placebo-controlled design. This means that participants will be randomly assigned to receive either the treatment or a placebo, and neither the participants nor the researchers will know who is receiving which until the study is completed. The study will also include a long-term extension period to gather more information about the treatment's effects over time.

Throughout the study, participants will be monitored for changes in their condition using a tool called the iADRS, which measures both cognitive abilities and daily functioning. The study aims to observe any changes from the start of the trial to the end, which is planned to last for several years. This research hopes to provide valuable insights into the potential benefits of JNJ-63733657 for individuals with Early Alzheimer's Disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be assigned to one of two groups. One group will receive the study medication, JNJ-63733657, and the other group will receive a placebo. A placebo is a substance with no active medication, used to compare the effects of the study medication.
Step 2
Initial assessment
You will undergo an initial assessment to evaluate your current health status and cognitive function. This may include various tests and questionnaires to establish a baseline for your condition.
Step 3
Medication administration
If you are in the group receiving the study medication, you will be given JNJ-63733657 as a solution for infusion. This means the medication will be administered directly into your bloodstream through a vein. The frequency and dosage will be determined by the study protocol and communicated to you by the study team.
Step 4
Regular follow-up visits
You will have regular follow-up visits with the study team. During these visits, your health and cognitive function will be monitored. This is to ensure your safety and to assess the effects of the medication or placebo.
Step 5
Long-term extension
The study includes a long-term extension period. If you continue to meet the study criteria, you may be eligible to participate in this phase, which allows for extended observation and treatment.
Step 6
Final assessment
At the end of the study period, a final assessment will be conducted. This will involve similar tests and evaluations as the initial assessment to measure any changes in your condition.

Who can join the trial?

5 criteria

Be between 55 to 80 years old at the time of giving initial consent.
Have early Alzheimer's Disease, which means a gradual and progressive decline in memory and thinking skills over at least the past 6 months, as reported by both the participant and a study partner.
Have a CDR-GS score of 0.5 and a memory box score of at least 0.5 at screening. The CDR-GS is a scale used to assess the severity of Alzheimer's Disease.
Show evidence of pathologic tau on a screening tau PET scan. This is a type of brain scan that looks for abnormal tau protein, which is associated with Alzheimer's Disease.
Have a designated study partner who can read and write well enough to participate and is likely to complete the study with the participant.

Who cannot join the trial?

3 criteria

Patients who do not have Early Alzheimer's Disease cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who belong to a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

JNJ-63733657 is a medication being studied for its potential to help people with early Alzheimer's disease. It is a type of treatment known as a monoclonal antibody, which is designed to target and bind to specific proteins in the brain. In this case, JNJ-63733657 targets a protein called tau, which is believed to play a role in the development and progression of Alzheimer's disease. By binding to tau, this medication aims to slow down or prevent the worsening of symptoms related to memory and thinking skills. The goal of the study is to see if JNJ-63733657 can help reduce the decline in cognitive and functional abilities in people with early Alzheimer's disease.

What is already known about the treatment

JNJ-63733657 – This medication is administered as an injection and is currently being studied in clinical trials for its potential to treat early Alzheimer's disease. It is an anti-tau monoclonal antibody, which means it targets and binds to tau proteins in the brain, potentially preventing or slowing the progression of Alzheimer's disease. The main goal of the ongoing study is to assess how well JNJ-63733657 can slow down the decline in cognitive and functional abilities in patients. As it is still in the trial phase, it is not yet widely available or fully approved for general medical use.

Investigated diseases

Early Alzheimer's Disease – Early Alzheimer's Disease is a neurodegenerative condition characterized by mild memory loss and cognitive difficulties. It primarily affects the brain's ability to process information, leading to challenges in remembering recent events or learning new information. As the disease progresses, individuals may experience confusion, difficulty with language, and changes in mood or behavior. The progression is gradual, with symptoms worsening over time, affecting daily activities and independence. It is associated with the accumulation of abnormal proteins in the brain, which disrupts normal brain function. The disease typically begins with subtle symptoms that gradually become more pronounced.