All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

This research, called DIAN-TU, is looking for people aged 18-80 who have a rare, inherited type of Alzheimer's disease. This type of Alzheimer's is caused by a specific faulty gene and tends to start earlier in life. The main goal is to test two new medicines, E2814 and Lecanemab, to see if they can help slow down the disease's progression. Researchers will be carefully checking if these treatments improve special markers in the brain and also if they help preserve people's thinking, memory, and daily abilities. The study aims to understand if an early treatment can make a real difference for those at risk of this genetic form of Alzheimer's.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
Washington University School of Medicine
Enrolment target
197
Start
22 Dec 2021
Estimated completion
01 Jul 2028

What is this study about?

This study is focused on a specific type of Alzheimer's disease that runs in families. This 'familial' type is caused by a faulty gene passed down through generations, and it often leads to symptoms appearing at a younger age than the more common form of Alzheimer's. The researchers are trying to find new ways to prevent or slow down this genetic form of the disease.

At the heart of Alzheimer's disease, including the familial type, are two main problems in the brain: sticky clumps called 'amyloid plaques' and twisted fibres called 'tau tangles'. These build up over time and cause damage to brain cells, leading to memory loss and difficulties with thinking. The study medicines aim to tackle these problems, hoping to either stop the plaques and tangles from forming or clear them away if they have already started to appear. By doing this early, the goal is to protect brain cells and keep thinking skills working better for longer.

Basically, the study wants to see if giving these new treatments early to people who are likely to get this genetic form of Alzheimer's can make a difference. They will measure changes in the brain (using special scans and tests) and also carefully check participants' memory, thinking, and daily abilities. The hope is that by intervening before or soon after symptoms start, it might be possible to slow down or even stop the disease from getting worse.

Key takeaways

  • This study is for a genetic, early-onset form of Alzheimer's disease.
  • It tests new medicines (E2814, Lecanemab) to slow disease progression.
  • Participation involves regular visits, brain scans, blood tests, and lumbar punctures.
  • You'll need a 'study partner' to provide additional information.
  • Joining is a long-term commitment and you might receive a placebo.

Who may be eligible?

This study is looking for people between 18 and 80 years old. A very important part of joining is that you must know you have the specific faulty gene that causes this early-onset, inherited type of Alzheimer's disease. You should also be within 10 years before or 10 years after the age when symptoms are expected to start, or have already started. You can be eligible if your memory and thinking are normal, or if you have very mild problems with memory or thinking (what doctors call mild cognitive impairment or mild dementia).

To take part, you'll need to be able to speak the study's approved language well and have a good level of understanding previously. You also need to be able to have brain scans (MRI, PET) and a lumbar puncture (a small test involving fluid from your spine). It's also important to have a 'study partner' – someone who knows you well and can give accurate information about your memory and daily activities.

There are also some reasons why you might not be able to join. For example, if you have other serious brain conditions, a high risk of suicide, or certain metal implants in your body that would make MRI scans unsafe. The study team will check all these details carefully with you.

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.

  1. Are you between 18 and 80 years old?
  2. Do you know you have the specific faulty gene for inherited Alzheimer's?
  3. Are you within 10 years before or 10 years after the expected start of symptoms?
  4. Do you have normal thinking or very mild memory/thinking problems?
  5. Are you able to have MRI brain scans and lumbar punctures?
  6. Do you have a friend or family member who can be your 'study partner'?
Answer every question to see your result.

What does participation involve?

If you join the study, you will receive either one of the new study medicines (E2814 or Lecanemab) or a 'matching placebo'. A placebo looks exactly like the study medicine but contains no active drug, and is used so researchers can fairly compare how the real medicine works. You won't know whether you're getting the active medicine or the placebo, and neither will your study doctor.

Your participation will involve regular visits to the study clinic, likely over several years. At these visits, you'll have various tests, including memory and thinking assessments, blood tests, and special brain scans (MRI and PET scans) to look at changes in your brain. You will also need to have lumbar punctures regularly, where a small amount of fluid is taken from your spine. Your study partner will also be asked to provide information about you at these visits. The exact duration and frequency of visits will be explained by the study team, but it's a long-term commitment.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as contributing to scientific understanding of Alzheimer's disease and potentially receiving a new treatment that isn't yet widely available. However, there are also potential risks, including side effects from the study medicines or discomfort from the tests (like scans or lumbar punctures). There is no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama in Birmingham
    Verified postcode
    Birmingham, United States
  • University of California San Diego Medical Center
    Verified postcode
    La Jolla, United States
  • USC Keck School of Medicine
    Verified postcode
    Los Angeles, United States
  • Yale University School of Medicine
    Verified postcode
    New Haven, United States
  • Emory University
    Verified postcode
    Atlanta, United States
  • Advocate Lutheran General Hospital
    Verified postcode
    Park Ridge, United States
  • Indiana University School of Medicine
    Verified postcode
    Indianapolis, United States
  • Washington University in St. Louis
    Verified postcode
    St Louis, United States
  • University of Pittsburgh
    Verified postcode
    Pittsburgh, United States
  • Butler Hospital
    Verified postcode
    Providence, United States
  • Kerwin Research Center,
    Verified postcode
    Dallas, United States
  • University of Washington
    Verified postcode
    Seattle, United States

Common questions

What is 'familial' Alzheimer's disease?

It's a rare type of Alzheimer's disease caused by a specific faulty gene that runs in families, often leading to symptoms at a younger age.

What are E2814 and Lecanemab?

These are the two investigational medicines being tested in the study, designed to target the underlying causes of Alzheimer's disease like amyloid plaques.

What is a 'placebo'?

A placebo looks like the study medicine but has no active ingredients. It's used for comparison to see if the real medicine actually works.

What is a 'lumbar puncture'?

It's a medical procedure where a small needle is used to collect a sample of fluid from your lower back, which gives important information about the brain.

Do I have to have a study partner?

Yes, having a study partner who knows you well is a key requirement, as they provide important information about your daily life and memory.

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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