Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects with Early Alzheimer's Disease

This research is investigating a new potential treatment, called ABBV-916, for people in the early stages of Alzheimer's disease. The main goal is to find out if the medication is safe and how well it works. Researchers will be especially looking to see if it can help reduce the build-up of amyloid plaques in the brain, which are a hallmark of Alzheimer's. They will use special brain scans to measure these changes. Some participants will receive the new medication, others will get a placebo (a dummy treatment), and some might receive another existing treatment also being studied. This is a Phase II study, meaning it's still in the early stages of testing but aims to gather important information for future development.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

Start

28 Jul 2023

Alzheimer's disease (AD)

What is this study about?

Imagine your brain as a super complex computer. In Alzheimer's disease, certain proteins can build up and gum up the works, like sticky plaques. We call these 'amyloid plaques'. Scientists believe these plaques play a big part in the memory and thinking problems that people with Alzheimer's experience.

This study, called 'ABBV-916', is looking at a new medication that might help to clear these plaques or stop them from forming in people who have early-stage Alzheimer's. The researchers want to understand if this new medication is safe for people to take and if it has any effect on these plaques in the brain. They'll be using special brain scans, called amyloid PET scans, to see if the amount of plaque changes after people take the medication.

This kind of study is really important because it helps us learn more about Alzheimer's and brings us closer to finding new ways to treat it. By studying new medications like ABBV-916, scientists hope to improve the lives of people living with this condition in the future.

Key takeaways

The study is investigating a new medication (ABBV-916) for early Alzheimer's disease.
It aims to check the medication's safety and effectiveness, especially on brain plaques.
Some participants will receive the new medication, some a different one, and others a placebo.
Special brain scans (amyloid PET scans) will monitor plaque levels.
Participation involves regular clinic visits and health assessments.
It is a Phase II study, meaning it's an early but important stage of research.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. This study is open to both men and women.

It's specifically for people who have been diagnosed with early Alzheimer's disease. The research team will do some tests to make sure you fit the exact criteria for 'early Alzheimer's' because it's important that all participants are similar for the study to work well.

There might be other health requirements or medications you're taking that could affect your ability to join, so the study team will discuss all of these details with you or your loved ones.

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 appointments at a study clinic?
Are you comfortable with undergoing brain scans (PET scans)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned by chance to one of several groups. You might receive the new study medication (ABBV-916), a different study medication (MK-6240), or a placebo. A placebo looks just like the real medicine but contains no active ingredient, and neither you nor the study team will know which you are receiving – this helps researchers see the true effect of the medication.

You would need to attend regular appointments at the study clinic for check-ups, blood tests, and to have those special brain scans (amyloid PET scans) at the beginning and after 24 weeks. These scans help measure if the plaques in your brain have changed. You would also have ongoing follow-up visits to monitor your health and how you’re responding. The total duration of your participation, including all visits and follow-ups, would be explained in full by the study team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving close medical attention and access to a new experimental treatment before it's widely available. Your participation also directly contributes to scientific knowledge, helping to advance our understanding of Alzheimer's disease. However, there are potential risks, including side effects from the study medication or procedures, which will be thoroughly explained. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Portugal
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Unverified
Italy
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Unverified
Spain

Common questions

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Why is this study 'double-blind'?

Double-blind means neither you nor the study doctors know if you're getting the new medicine or the placebo. This helps prevent bias and ensures fair results.

What are 'amyloid plaques'?

Amyloid plaques are sticky clumps of protein that build up in the brains of people with Alzheimer's disease. Scientists believe they disrupt brain function.

What is an 'amyloid PET scan'?

It's a special brain scan that can show doctors where and how much amyloid plaque is present in your brain. It helps measure changes over time.

Is this a new medication?

Yes, ABBV-916 is an investigational new medication. This study is an important step in finding out if it is safe and effective for people with early Alzheimer's.