Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants with Alzheimer's Disease

This ongoing study is investigating a new treatment, AL002, for people living with Alzheimer's disease. It’s an extension of an earlier study, meaning participants who have previously taken AL002 are continuing to receive care and be monitored. The main goals are to understand the long-term safety of AL002, see if people tolerate it well (meaning they don't have too many uncomfortable side effects), and check if it continues to help with Alzheimer's symptoms. Researchers will be observing various health aspects, like vital signs, blood tests, eye exams, and brain scans to ensure participants’ well-being and track the treatment's effects. The study involves adults aged 18 and over, of any gender.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Alector LLC

Enrolment target

178

Start

30 Nov 2023

Alzheimer's Disease

What is this study about?

This study is an important step in understanding a new treatment called AL002 for Alzheimer's disease. If you or a loved one is living with Alzheimer's, you might know that researchers are constantly working to find new and better ways to manage the condition. This particular study is called an 'extension study,' which means it's for people who have already participated in an earlier phase of research for AL002.

The main aim of this study is to gather more information over a longer period. We already have some initial information about AL002 from the first part of the study, but it's really important to see how it works and what effects it might have in the long run. The researchers will be looking closely at how safe the treatment is, how well people tolerate it, and if it continues to be effective in helping with the symptoms of Alzheimer's.

Throughout the study, the medical team will keep a close eye on participants' health. This includes routine checks like blood pressure and heart rate, along with more specific tests such as blood tests, eye exams, and special brain scans (MRI). They will also look for any side effects, including specific ones related to brain swelling or bleeding, which are sometimes seen with new Alzheimer's treatments. This careful monitoring helps ensure participants' safety and provides a full picture of the treatment's effects. The hope is that AL002 could offer a new way to help people with Alzheimer's disease in the future.

Key takeaways

This study explores a new long-term treatment (AL002) for Alzheimer's disease.
It focuses on understanding the safety and effectiveness of AL002 over time.
Participants must have already been in an earlier study for AL002.
Regular health checks, including brain scans, are an important part of the study.
The study aims to see if AL002 can offer a new option for managing Alzheimer's.

Who may be eligible?

This study is looking for adults who have been diagnosed with Alzheimer's disease. You would need to be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to participate.

Since this is an 'extension study,' it means that to be considered, you would typically have already been part of an earlier study involving AL002. This helps researchers gather continuous information from people who have already started the treatment. The research team will review your past medical records and current health to determine if you are a good fit for this particular phase of the study.

Quick self-check

Are you at least 18 years old?
Have you been diagnosed with Alzheimer's disease?
Have you previously taken part in an earlier study for AL002?
Are you able to attend regular clinic appointments for treatment and check-ups?

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

What does participation involve?

If you join this study, you would continue to receive the study medication, AL002, through an intravenous infusion (a drip into your arm). The specific schedule for these infusions and how long you would receive treatment would be explained to you by the study team, but it's designed to gather long-term safety and effectiveness data. You would have regular visits to the study clinic for various assessments. These visits would involve checking your vital signs (like blood pressure and heart rate), taking blood and urine samples, and having detailed physical and neurological exams. You might also have regular eye exams, ECGs (heart tracings), and MRI scans of your brain to monitor for any changes. The total duration of participation in this long-term extension study can vary for individuals, depending on how long they were in the initial study and the overall study design, but it typically involves many months or even a few years of follow-up.

Potential risks and benefits

Participating in a study like this could potentially offer some benefits, such as receiving a new investigational treatment for Alzheimer's disease that isn't yet widely available, and having your health closely monitored by a dedicated medical team. However, with any new treatment, there are also potential risks. You might experience side effects from the medication, and some tests and procedures, like having blood drawn or MRI scans, can be uncomfortable or carry minor risks. The study team will explain all known potential risks in detail before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (6)

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Germany
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Netherlands
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Spain
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Poland
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Italy
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France

Common questions

What is AL002?

AL002 is a new investigational medication being studied for Alzheimer's disease. It's a type of antibody, which is a substance that targets specific things in your body.

Is this study safe?

The researchers will very carefully track your health, including vital signs, blood tests, and brain scans, to check for any problems and make sure the study is as safe as possible for participants.

Will I definitely get the new treatment?

Since this is an extension study, participants would typically have received AL002 in an earlier part of the study. You're not likely to receive a placebo (dummy treatment) in this extension phase if you were already on the active drug.

What's a 'Phase II' study?

Phase II means the treatment has already passed initial safety tests in a small group of people. In this phase, researchers are looking at how well it works and confirming its safety in a larger group of people with the condition.

How long will the study last for me?

Participation in this long-term study can vary. The study team will be able to give you specific details about the expected duration based on your individual situation and the study plan.