A PHASE 2, SINGLE-ARM STUDY OF THE BIOMARKER EFFECTS OF ALZ-801 IN SUBJECTS WITH EARLY ALZHEIMER’S DISEASE WHO ARE CARRIERS OF THE ε4 VARIANT OF THE APOLIPOPROTEIN E GENE (APOE4/4 or APOE3/4)
This study is researching a new medication called ALZ-801 for individuals with early-stage Alzheimer's disease. Participants must carry specific genetic markers (APOE4/4 or APOE3/4) that are linked to the disease. The main goal is to understand how ALZ-801 impacts specific substances in the blood and changes in brain volume over a period of 104 weeks (about two years). There are also plans for a longer follow-up, extending to 156 and 208 weeks. Researchers will measure these changes to see if the drug is effective. They will also look at other factors like safety, side effects, and how well the drug is tolerated by the body. This is a Phase 2 study, which means it's an early step in testing the drug in people to learn more about its effects and safety.
At a glance
What is this study about?
This study is designed to explore a new drug called ALZ-801, specifically for people in the early stages of Alzheimer's disease. The researchers are particularly interested in individuals who have certain genetic traits, known as APOE4/4 or APOE3/4. These genetic markers are known to increase the risk of developing Alzheimer's disease.
The main purpose of this study is to see how the drug ALZ-801 affects certain biological markers related to Alzheimer's. For example, they'll be looking at levels of a protein called p-tau181 in the blood, which is linked to the disease. They will also use special brain scans (MRIs) to measure changes in the size of a part of the brain called the hippocampus, which is important for memory and often shrinks in Alzheimer's. By tracking these subtle changes over two years, with potential follow-ups for up to four years, the researchers hope to understand if ALZ-801 can help slow down the disease process.
This is a 'Phase 2' study, meaning it's still in the early stages of testing in humans. The goal isn't just to see if the drug works, but also to understand how safe it is and what side effects it might have. This detailed information helps scientists decide if the drug should move on to larger studies. By carefully monitoring participants and taking various measurements, they aim to build a clearer picture of ALZ-801's potential to treat early Alzheimer's disease.
Key takeaways
- This study is testing a new drug for early Alzheimer's disease.
- It's for people aged 50-80 years with specific genetic markers (APOE4/4 or APOE3/4).
- Researchers will check blood markers and brain scans to see the drug's effects.
- The study lasts at least two years, with options for longer follow-up.
- Participation involves regular clinic visits, blood tests, and MRI scans.
Who may be eligible?
To be considered for this study, you would need to be diagnosed with Alzheimer's disease and be in the early stages of the condition. You would also need to be between 50 and 80 years old.
A key requirement for joining is having specific genetic markers. These are known as APOE4/4 or APOE3/4. Your doctor can help determine if you have these markers through a genetic test. All genders are welcome to participate. The study team will review all aspects of your health to confirm if it's right for you.
- I have been diagnosed with Alzheimer's disease.
- My Alzheimer's disease is in its early stages.
- I am between 50 and 80 years old.
- I know if I have the APOE4/4 or APOE3/4 genetic markers (or I'm willing to find out).
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study means you would receive the study drug, ALZ-801. You would have regular visits to the clinic over a period of at least two years (104 weeks). There's also the option to continue in a longer follow-up period for up to four years in total.
During these visits, a variety of assessments will be carried out. These include blood tests to check specific markers related to Alzheimer's disease and for general health and safety. You would also undergo special brain scans (MRIs) to look at brain changes. Heart tests (ECGs) and physical examinations will also be part of the routine check-ups. You'll also likely complete some memory and thinking tests to track your cognitive abilities over time. The study staff will explain all procedures in detail before you decide to join.
Potential risks and benefits
Locations (2)
- —Czechia
- —Netherlands
Common questions
What is ALZ-801?
ALZ-801 is a new drug being tested for people with early Alzheimer's disease. It's not yet approved for general use.
What are APOE4/4 or APOE3/4?
These are genetic markers that tell us about a person's genes. Having these specific markers can be linked to a higher risk of developing Alzheimer's disease.
What is a 'Phase 2' study?
This means the drug is in an early stage of testing in people. Researchers are trying to learn more about its effects, safety, and how the body handles it, before moving to larger studies.
How long would I be in the study?
The main part of the study lasts about two years (104 weeks), with options to continue for an additional one or two years if you choose.
Will I receive the new drug?
Yes, if you participate in this study, you will receive doses of the investigational drug ALZ-801.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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