A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation
This research study is investigating a new drug called remternetug for a specific type of early-onset Alzheimer's disease that runs in families. This condition is caused by a faulty gene. The study is for people who are at risk of developing this condition but don't yet have any symptoms. The main goal is to find out if remternetug can prevent or reduce the build-up of a protein called amyloid beta in the brain, which is linked to Alzheimer's. Researchers will also check how safe remternetug is, any possible side effects, and how well people tolerate it. The hope is that by treating the disease early, before symptoms start, we might be able to slow down its progression.
At a glance
What is this study about?
This research is looking at a new treatment called remternetug for a specific type of Alzheimer's disease. This particular kind of Alzheimer's often starts earlier in life and is passed down through families because of a faulty gene. The study is for people who carry this faulty gene and are therefore at high risk of developing the disease, even if they don't have any symptoms yet.
Scientists believe that a protein called amyloid beta building up in the brain is a very early step in Alzheimer's disease. The idea behind this study is that if we can stop or slow down this build-up, we might be able to delay or even prevent the disease from getting worse. This study will carefully check if remternetug can indeed reduce these amyloid beta plaques in the brain. They'll also be looking at other signs of the disease using brain scans, blood tests, and spinal fluid tests, as well as keeping a close eye on safety and how participants feel while taking the treatment.
What makes this study particularly important is that it focuses on treating the disease very early, before symptoms even appear. It's thought that this early intervention could have the best chance of slowing the disease down. By working with individuals who are known to be at risk because of their family history, researchers can study the effects of the treatment at the earliest possible stage.
Key takeaways
- This study is testing a new drug for inherited, early-onset Alzheimer's disease in people without symptoms.
- The drug, remternetug, aims to reduce harmful protein build-up in the brain.
- Participation involves regular clinic visits, scans, blood tests, and spinal fluid tests.
- It's a 'blinded' study, meaning you won't know if you're getting the active drug or a placebo.
- The goal is to find ways to prevent or significantly delay Alzheimer's disease.
- Your well-being will be closely monitored throughout the study.
Who may be eligible?
To be able to join this study, you need to be at least 18 years old. A key requirement is that you must carry a specific faulty gene (in the APP, PSEN1, or PSEN2 family) that causes a type of Alzheimer's disease that runs in families. If you don't know your gene status but a close family member has one of these mutations, you might still be able to join.
Crucially, you must not have any symptoms of Alzheimer's disease yet. This means your memory and thinking skills should be normal according to standard checks. The study is specifically for people who are expected to develop symptoms in the next 11 to 25 years, based on their family history and gene type. Participants also need to be able to understand and speak a language used in the study materials, and a study partner (like a trusted family member or friend) will also need to be involved to help with providing information.
For women who could become pregnant, there are specific rules. You'll need to have a negative pregnancy test and agree not to try to get pregnant or breastfeed during the study and for a period afterwards. If your partner could father a child, you'll need to use highly effective contraception during the study and after the last dose of medication.
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 at least 18 years old?
- Do you have a specific faulty gene linked to early-onset Alzheimer's, or is there a family history of such a gene?
- Do you currently have no symptoms of Alzheimer's disease, and are your memory and thinking normal?
- Are you able to attend regular clinic visits and have brain scans, blood tests, and spinal fluid tests?
- If you could become pregnant, are you willing to follow strict contraception and breastfeeding rules?
What does participation involve?
If you decide to take part, you'll be given either the study drug, remternetug, or a matching placebo (a dummy drug with no active ingredients). Which one you get is decided by chance, like flipping a coin. You won't know if you're getting the active drug or the placebo, and neither will the study team.
The study involves regular visits to the clinic for various checks. These will include brain scans (to look for amyloid beta), blood tests, and spinal fluid tests. These tests help the researchers see how the treatment is affecting the disease at a biological level. You’ll also have regular assessments of your memory and thinking skills to ensure your cognitive abilities remain normal. A study partner will also be asked to provide information about your daily life. The total duration of your participation in the study will be determined by the researchers and will involve ongoing follow-up to monitor the long-term effects.
Potential risks and benefits
Locations (35)
- University of Alabama in BirminghamVerified postcodeBirmingham, United States· Recruiting
- University of California San Diego Medical CenterVerified postcodeLa Jolla, United States· Recruiting
- Yale University School of MedicineVerified postcodeNew Haven, United States· Recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Recruiting
- Advocate Lutheran General HospitalVerified postcodePark Ridge, United States· Recruiting
- Indiana University School of MedicineVerified postcodeIndianapolis, United States· Recruiting
- Washington University in St. LouisVerified postcodeSt Louis, United States· Recruiting
- New York University Medical CenterVerified postcodeNew York, United States· Recruiting
- University of PittsburghVerified postcodePittsburgh, United States· Recruiting
- Butler HospitalVerified postcodeProvidence, United States· Recruiting
- Kerwin Research and Memory CenterVerified postcodeDallas, United States· Recruiting
- University of WashingtonVerified postcodeSeattle, United States· Recruiting
Common questions
What is remternetug?
Remternetug is the name of the new drug being tested in this study to see if it can help prevent or slow down Alzheimer's disease.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the study drug but contains no active ingredients. It helps researchers compare the effects of the active drug.
Why is it important that I don't have symptoms yet?
This study aims to treat Alzheimer's super early, before symptoms appear, as researchers believe this might be the best time to stop the disease from developing further.
What is an amyloid beta protein?
Amyloid beta is a protein that can build up in the brain and is thought to be a very early sign of Alzheimer's disease.
What kind of tests will I have?
You'll have brain scans, blood tests, and spinal fluid tests to check for signs of the disease, along with memory and thinking skill assessments.
How to find out more
Jamie Bartzel
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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