Active not recruitingPHASE3INTERVENTIONAL

Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

This study is a continuation of a previous clinical trial for ALZ-801, a drug being tested for early Alzheimer's disease. It focuses on individuals who have two copies of the APOE4 gene, which is known to increase the risk of Alzheimer's. The main goal is to find out if ALZ-801 is safe and effective over a long period. All participants in this part of the study will receive ALZ-801. Researchers will continue to monitor memory, thinking abilities, and overall daily function. They will also look at how the drug affects the brain using scans and other tests. Participants will receive ALZ-801 for about two years, followed by a short check-up period.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alzheon Inc.

Enrolment target

163

Start

02 Apr 2024

Estimated completion

01 Jun 2026

Early Alzheimer's Disease

What is this study about?

This study is an important next step in understanding how a drug called ALZ-801 might help people with early Alzheimer's disease. It's a special kind of study because it's a long-term continuation for people who have already started taking part in a previous study of ALZ-801. The focus is on individuals who have a particular genetic make-up called APOE4/4, which means they have inherited two copies of the APOE4 gene. This gene is strongly linked to a higher risk of developing Alzheimer's disease. By studying people with this specific genetic profile, researchers hope to learn more about how ALZ-801 works and who it might help the most.

The main reasons for doing this study are to continue checking the safety of ALZ-801 over a longer time and to see how well it works at slowing down or helping with the symptoms of early Alzheimer's. The participants in this study will all receive ALZ-801. Even though everyone will get the active drug now, the study team, the participants, and their study partners won't know whether the participants received the active drug or a dummy treatment (placebo) in the original study. This helps keep the results unbiased.

Throughout the study, doctors and researchers will regularly check memory, thinking skills, and how well people can manage their daily activities. They will also use special brain scans and other tests to look for changes in the brain that might be related to Alzheimer's disease. This long-term information is crucial for understanding the full benefits and any potential downsides of ALZ-801.

Key takeaways

This is a long-term study for people already participating in an ALZ-801 trial.
It focuses on individuals with early Alzheimer's and a specific genetic make-up (APOE4/4).
All participants in this part of the study will receive ALZ-801.
The study aims to check the safety and effectiveness of ALZ-801 over an extended period.
Regular visits, memory tests, and brain scans will be part of the process.
A study partner is essential for providing information about your condition.

Who may be eligible?

To be part of this study, you must have already completed 78 weeks (about a year and a half) of the main ALZ-801 study while taking the study medication. You also need a trusted study partner, like a family member or close friend. This partner needs to spend enough time with you to accurately tell the study team about your memory, thinking, and daily activities.

There are also some reasons why you might not be able to join. These include if your other health conditions have gotten significantly worse in a way that could make it difficult to complete the study. You also cannot join if you have experienced certain brain changes (called ARIA) that cause symptoms or are considered moderate to severe, as seen on brain scans.

Additionally, you cannot participate if you have received or plan to receive other specific Alzheimer's treatments called 'amyloid antibodies' since finishing the first part of the study. Finally, if you are currently taking any medications that are not allowed by the study rules, you would not be able to join.

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.

Have I completed 78 weeks of the previous ALZ-801 study while on the study drug?
Do I have a reliable study partner who knows me well?
Are my other health conditions stable and not significantly worse?
Have I avoided taking certain other Alzheimer's medications (amyloid antibodies) since the previous study?
Am I currently not taking any medications that are prohibited by the study rules?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the ALZ-801 medication for about two years (104 weeks). You will have regular visits to the study clinic during this time for checks and tests. These visits will help the doctors see how you are doing, if the medication is helping, and if there are any side effects. After you finish taking ALZ-801, you will have one final check-up visit about four weeks later to make sure you are well. Your study partner will also be an important part of these visits, providing information about you to the study team. Throughout the entire study, neither you, your study partner, nor the study staff will know whether you received the active drug or a dummy treatment in the previous study you participated in. The total duration of your active participation will be approximately 108 weeks.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational drug that could potentially help with early Alzheimer's disease. You would also receive close medical attention and monitoring throughout the study. However, like all medications, ALZ-801 may have side effects, and some tests involve risks, although measures are taken to minimise these. There's no guarantee that the drug will be effective for you, and it may not improve your condition. You have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (41)

Xenoscience, Inc.
Verified postcode
Phoenix, United States
Banner Sun Health Research Institute
Verified postcode
Sun City, United States
ATP Clinical Research
Verified postcode
Costa Mesa, United States
Torrance Clinical Research Institute
Verified postcode
Lomita, United States
Sutter Health
Verified postcode
Sacramento, United States
JEM Research Institute, Headlands Site
Verified postcode
Atlantis, United States
K2 Medical Research, LLC
Verified postcode
Maitland, United States
Mount Sinai Medical Center
Verified postcode
Miami Beach, United States
Aqualane Clinical Research
Verified postcode
Naples, United States
Charter Research
Verified postcode
Orlando, United States
Progressive Medical Research
Verified postcode
Port Orange, United States
ALZ Research and Treatment Center (A.R.T.C.)
Verified postcode
Stuart, United States

Common questions

What is ALZ-801?

ALZ-801 is an experimental drug being tested to see if it can help people with early Alzheimer's disease.

What does 'APOE4/4 genotype' mean?

This means you have two copies of a specific gene (APOE4) that is linked to a higher risk of developing Alzheimer's disease.

Will I take ALZ-801 or a dummy drug?

Everyone in this particular long-term study will receive the active drug, ALZ-801.

How long will I be in the study?

You will take ALZ-801 for about two years (104 weeks), followed by one final check-up visit about a month later.

What is a 'study partner'?

A study partner is often a family member or close friend who can reliably tell the study team about your daily life and abilities.