A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study with a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer's Disease
This clinical trial is looking into a new medicine called JNJ-63733657 for individuals in the early stages of Alzheimer's disease. The main goal is to find out if this medicine is safe to use and if it can help improve memory, thinking, and daily activities over a period of two years. To do this, some participants will receive the new medicine, and others will get a placebo – a dummy drug that looks the same but has no active ingredients. This helps researchers fairly compare the effects. The study also uses a special scan called florquinitau F18 to help understand the disease better. The hope is to find new and effective ways to manage early Alzheimer’s.
At a glance
What is this study about?
This research study is focused on people who have been diagnosed with early Alzheimer's disease. Alzheimer's is a condition that affects memory, thinking, and the ability to do everyday tasks. Finding new ways to help manage these symptoms and slow down the disease's progression is very important.
The study is testing a new medicine called JNJ-63733657. This medicine is a type of 'monoclonal antibody,' which is a treatment designed to target specific things in the body. In this case, it's designed to target something called 'tau,' which is a protein that builds up in the brains of people with Alzheimer's disease and is thought to play a role in its development. Researchers want to see if this medicine can make a real difference for people with early Alzheimer's.
To make sure the study is fair and accurate, some participants will receive the active medicine, while others will receive a placebo. A placebo is a treatment that looks exactly like the real medicine but contains no active ingredients. This 'double-blind' approach means neither the participant nor their study doctor will know who is getting the active medicine. This helps ensure that any changes observed are truly due to the medicine and not other factors. The study will also be using special brain scans to help understand the effects of the medicine even better.
Key takeaways
- Tests a new medicine (JNJ-63733657) for early Alzheimer's.
- Aims to check safety and effectiveness over two years.
- Compares the new medicine against a dummy drug (placebo).
- Involves regular clinic visits, tests, and potentially brain scans.
- Open to adults aged 18 and over with early Alzheimer's disease.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you must have been diagnosed with early Alzheimer's disease. The study team will check your medical records and perform some tests to make sure that you meet the specific criteria for 'early Alzheimer's' that they are looking for.
There might be other health conditions or medicines that could prevent you from taking part, to ensure your safety and the accuracy of the study results. The study doctor will discuss all of these with you in detail.
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 18 years old or older?
- Have you been diagnosed with early Alzheimer's disease?
- Are you able to attend regular clinic appointments for about two years?
- Are you comfortable with the possibility of receiving a placebo?
- Are you willing to undergo various tests, including blood tests and possibly brain scans?
What does participation involve?
If you decide to join this study, it would last for about two years. During this time, you would have regular visits to the study clinic, where you would receive the study medicine (either JNJ-63733657 or a placebo). The medicine will likely be given as an injection or infusion.
At these visits, you'd have various tests and assessments. These would include memory and thinking tests, blood tests, and possibly brain scans (like the florquinitau F18 scan) to track any changes. You would also be asked about your general health and any side effects you might experience. There will be follow-up calls or visits even after the main treatment period to ensure your well-being.
Potential risks and benefits
Locations (5)
- —UnverifiedSweden
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedNetherlands
- —UnverifiedSpain
Common questions
What is 'Early Alzheimer's Disease'?
Early Alzheimer's Disease refers to the initial stages of the condition, where memory and thinking problems are present but are still mild and don't significantly affect daily life yet.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active ingredients. It's used to compare against the active drug to see if the medicine really works.
Will I know if I'm getting the real medicine or the placebo?
No, in this 'double-blind' study, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps ensure unbiased results.
What is 'florquinitau F18'?
Florquinitau F18 is a special substance used in a brain scan to help doctors see and study certain changes in the brain that are linked to Alzheimer's disease.
How long will I be in the study?
The study will last for about two years, which includes the active treatment period and some follow-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.