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

A phase 1, controlled, open-label, single dose, dose-escalation, clinical proof-of-concept study of MRI enhanced with ADx-001 (DSPE-DOTA-Gd Liposomal Injection) in patients with brain amyloid deposits as demonstrated by amyloid PET

This early-stage study is exploring a new injection called ADx-001. Researchers want to see if this injection, given before an MRI scan, can help doctors get clearer pictures of amyloid deposits in the brain. Amyloid deposits are clusters of proteins often found in the brains of people with Alzheimer's disease. The study is a 'Phase 1' trial, which means it's one of the first times this new injection is being given to humans. They will start with small doses and gradually increase them to find a safe and effective amount. The main goal is to understand if it works as expected and without serious side effects. People with Alzheimer's disease who have these amyloid deposits in their brain, as shown by a special PET scan, might be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Alzeca Biosciences Inc.

Enrolment target

Start

17 Jan 2025

Alzheimer's disease

What is this study about?

This study is about a new approach to improving how we detect early signs of Alzheimer's disease using a common scanning technique called an MRI. MRI scans use strong magnets and radio waves to create detailed pictures of organs and tissues inside your body, including your brain. Sometimes, doctors use special dyes or injections (called contrast agents) to make these pictures even clearer and highlight specific areas.

In this research, scientists are testing a new injection called ADx-001. The idea is that when ADx-001 is given before an MRI, it might stick to certain protein clumps, called amyloid deposits, that build up in the brains of people with Alzheimer's disease. If it lights up these deposits on the MRI, it could make them easier to see. This could potentially help doctors diagnose Alzheimer's earlier or track how the disease is progressing.

This is a 'Phase 1' study, which is the very first step in testing a new treatment or diagnostic tool in people. The main goals at this stage are to check if the injection is safe, what side effects it might have, and how the body handles it. Researchers will also be carefully watching to see if ADx-001 actually does help improve the MRI pictures of amyloid deposits, as they hope. It’s an important first step to see if this new approach works as they expect.

Key takeaways

This study is testing a new injection (ADx-001) for the first time in people.
The goal is to see if ADx-001 helps MRI scans show amyloid deposits in the brain more clearly.
It's an early-stage study focusing on safety and how the injection works.
Participants must have Alzheimer's disease and confirmed amyloid deposits.
You will receive a single injection and have an MRI scan, with follow-up monitoring.
Participation helps research into better ways to detect Alzheimer's disease.

Who may be eligible?

To be considered for this study, participants need to be adults, 18 years old or older. Both men and women can take part. A key requirement is that you must have a diagnosis of Alzheimer's disease.

Another important condition is that you must already know you have 'amyloid deposits' in your brain. These are specific protein clumps linked to Alzheimer's, and their presence would have been confirmed by a special brain scan called an amyloid PET scan before you join this study.

There might be other reasons why someone can't join, like having certain other health conditions or taking particular medications. The study team will review all your health information carefully to see if it's safe and appropriate for you to participate.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Alzheimer's disease?
Have you had an amyloid PET scan that confirmed you have amyloid deposits in your brain?
Are you able to undergo an MRI scan?
Are you generally in good health other than your Alzheimer's diagnosis?

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 in this study, you would first have a full health check-up, including blood tests and possibly other scans, to make sure you meet all the requirements. You would then receive a single injection of the study drug, ADx-001. This injection is given into a vein, similar to how blood is taken.

After receiving the injection, you would have an MRI scan of your brain. The research team would closely monitor you for a period after the injection and scan to check for any side effects. You would also have follow-up visits, which might include further medical checks and possibly more scans or blood tests, to see how the injection was processed by your body and to continue checking your health. The total duration of your participation would depend on the study's specific design, involving several visits over a period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is helping researchers learn more about diagnosing Alzheimer’s disease, which could lead to better detection methods in the future. You wouldn't directly benefit from the injection itself, as it's for imaging, not treatment. However, you would receive careful medical monitoring. Potential risks could include side effects from the injection, such as mild discomfort at the injection site, allergic reactions, or other unexpected reactions, though these are typically rare in early-stage studies with close monitoring. You will be closely monitored for any reactions, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is an 'amyloid deposit'?

Amyloid deposits are clumps of a specific protein that can build up in the brain. They are a common feature seen in the brains of people with Alzheimer's disease.

What is a 'Phase 1' study?

A Phase 1 study is the first time a new medicine or injection is given to humans. The main goal is to check if it's safe and to find the right dose, rather than to treat a disease.

Will I receive treatment for Alzheimer's in this study?

No, this study is not testing a treatment for Alzheimer's. It's looking at an injection that might help improve MRI scans for detecting amyloid deposits.

Is the injection painful?

The injection is given into a vein, similar to a blood test, so you might feel a brief sting or pressure. The study team will make sure you are as comfortable as possible.

How long will I be involved in the study?

The exact duration will vary, but it will involve several visits over a period, from initial health checks to follow-up appointments after the injection and MRI scan.