Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

This research study is testing a new medicine, called IBC-Ab002, for individuals who have been diagnosed with early stages of Alzheimer's disease. This is a very early-stage study, meaning it's the first time this particular medication is being given to people. The main goal is to check how safe the medicine is, what side effects it might have, and how it behaves in the human body. Researchers want to understand if it could be a helpful treatment in the future. It's a key first step in developing new ways to manage Alzheimer's disease, focusing on understanding the new medicine before testing if it can improve symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Immunobrain Checkpoint Ltd.

Enrolment target

Start

28 Jun 2024

Alzheimer's disease

What is this study about?

This study is about a new medicine, which we'll call IBC-Ab002, designed for people who have Alzheimer's disease in its early stages. Think of clinical trials in phases, like steps. This study is in the very first step, called Phase 1. This means it's the very first time this specific medicine is being given to people. Before this, it would have been tested carefully in labs.

The main reason for this first step is to check if the new medicine is safe for people. Doctors and researchers will be looking very closely at how the body reacts to it, what side effects might happen, and how much of the medicine stays in the body over time. It's not about seeing if the medicine cures Alzheimer's yet, but rather gathering important information about its safety and how it works in people.

Finding new treatments for Alzheimer's disease is very important. Studies like this, even at the earliest stages, are crucial because they help us understand if a new medicine has the potential to help people in the future. If this first study shows the medicine is safe, then more studies will follow to see if it can actually make a difference to people's health.

Key takeaways

This study is testing a brand-new medicine, IBC-Ab002, for early Alzheimer's disease.
It's the very first time this medicine is being given to people (Phase 1 study).
The main aim is to check if the medicine is safe and how it works in the human body.
Participation means contributing to future Alzheimer's treatments, but there's no guarantee of personal benefit.
You would be closely monitored by medical staff if you take part.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate if they meet other health requirements.

The most important requirement is that you must have an early form of Alzheimer's disease. The researchers will need to confirm this diagnoses to ensure the study is right for you. They will also check other health factors to make sure it's safe for you to take part.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of early Alzheimer's disease?
Are you able to attend regular appointments at a study clinic?
Are you willing to follow study instructions and undergo medical tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the new medicine, IBC-Ab002. Since this is an early-stage study, there will likely be several visits to the study clinic. These visits are important for the research team to monitor your health closely, check for any possible side effects, and see how the medicine is affecting your body. You might have regular tests like blood samples, physical exams, and possibly brain scans or memory tests. The exact number of visits and the full length of your participation would be explained to you, but typically, these early studies involve close monitoring over a period of weeks or months, followed by some follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be contributing to medical science and helping to develop new treatments for Alzheimer's disease, which might eventually help you or others. However, as this is a new medicine, the main risk is that we don't yet know all the possible side effects or how your body will react. There is also no guarantee that the medicine will help your condition. You would be closely monitored for your safety, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a condition that affects the brain, causing problems with memory, thinking, and behaviour. It usually gets worse over time.

What does 'early Alzheimer's disease' mean?

It means someone has been diagnosed with Alzheimer's disease, but their symptoms are still mild and haven't progressed significantly.

What is a 'Phase 1' study?

Phase 1 is the first time a new medicine is given to humans. The main goal is to check for safety, how the body handles the medicine, and find the right dose.

Will I get better if I join this study?

The goal of this early study is mainly to check safety and how the medicine works, not to see if it cures or improves your condition yet. There's no guarantee the medicine will help you personally.

Who is running this study?

Clinical trials like this are usually run by experienced research doctors and nurses in hospitals or clinics, under strict rules to ensure safety and ethical conduct.