AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
This research study, called AHEAD 3-45, is looking into a new treatment called lecanemab. It's for people who are in the very earliest stages of Alzheimer's disease, meaning they don't have any noticeable memory issues yet but show early signs in their brain. The study aims to find out if lecanemab works better than a placebo (a dummy medicine) at slowing down changes in thinking and reducing certain proteins in the brain linked to Alzheimer's. There are two main parts: one for people with slightly more protein build-up, and another for those with intermediate levels. It will also check how safe the medicine is over a long time. This is a Phase 3 trial, which means it’s a big study to see if a new treatment is effective and safe.
At a glance
What is this study about?
This study, called AHEAD 3-45, is a really important research project looking into Alzheimer's disease. We know that Alzheimer's begins in the brain many years before people show any outward signs like memory loss. This study focuses on these very early stages, sometimes called 'preclinical Alzheimer's', where changes are happening in the brain, but everyday life isn't affected yet.
The main goal is to test a new medicine called lecanemab. Researchers want to see if this medicine can help slow down or stop the very early changes in the brain that lead to Alzheimer's. Specifically, they're looking at whether it can reduce a protein called amyloid, which builds up in the brains of people with Alzheimer's. They also want to understand if it can help maintain thinking and memory skills over time. To do this, some participants will receive lecanemab, while others will get a placebo (a dummy medicine with no active ingredients) to fairly compare the effects. This is a 'double-blind' study, meaning neither you nor your study doctor will know which you are receiving, which helps ensure the results are as accurate as possible.
This study is split into two parts based on the level of amyloid protein found in the brain. The 'A45 Trial' is for people with already elevated levels of amyloid, while the 'A3 Trial' is for those with intermediate levels. Both groups will help researchers understand how lecanemab works across different early stages of the disease. Ultimately, the hope is that this research could lead to new ways of preventing or significantly delaying Alzheimer's symptoms.
Key takeaways
- This study is for people with very early brain changes related to Alzheimer's, but no memory problems.
- It tests a new medicine called lecanemab against a dummy medicine (placebo).
- The main goals are to see if lecanemab can reduce harmful brain proteins and preserve thinking skills.
- Participants need to be 55-80 years old and have specific brain scan results.
- A study partner who knows you well is required to help provide information.
- Participation involves regular clinic visits, tests, and medication infusions over several years.
Who may be eligible?
To join this study, you would need to be between 55 and 80 years old. A key requirement is that tests show you have either intermediate or elevated levels of amyloid protein in your brain. This can be checked through a special brain scan (PET scan), spinal fluid test, or a blood test.
If you are between 55 and 64 years old, you'd also need to meet one of these additional conditions: either a close family member (like a parent or sibling) developed dementia before age 75, or you know you carry a specific gene called APOE4, which increases the risk of Alzheimer's.
Critically, all participants must not have any memory problems or difficulties in their daily life that are noticeable to a doctor. You would need to score well on certain memory and thinking tests during screening. You'd also need a 'study partner' – someone who knows you well, sees you regularly (at least weekly), and can provide information about your daily routine and mood.
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 between 55 and 80 years old?
- Do you have early signs of amyloid protein in your brain (confirmed by special tests)?
- If you're under 65, do you have a family history of dementia or carry the APOE4 gene?
- Do you currently have excellent memory and thinking skills, with no noticeable problems?
- Do you have a friend or family member who knows you well and could be your regular 'study partner'?
- Are you able to attend regular clinic appointments for several years?
What does participation involve?
Taking part in this study would involve regular visits to the clinic over a number of years, possibly up to four years, plus a follow-up period. During these visits, you would have check-ups with doctors, possibly provide blood samples, and undergo special brain scans (PET scans) to monitor changes in your brain. You would also complete various memory and thinking tests.
Each participant would receive either the study medicine, lecanemab, or a placebo (a dummy medicine). Neither you nor your study doctor would know which one you are getting. The medicine would likely be given as an infusion into a vein at the clinic. Your study partner would also be involved by answering questions about you during your appointments. The total time you'd be in the study would be about 216 weeks (around 4 years), with the possibility of being asked to continue into an 'extension phase' to track long-term safety and effects.
Potential risks and benefits
Locations (107)
- University of Alabama, BirminghamVerified postcodeBirmingham, United States
- Banner Alzheimer's InstituteVerified postcodePhoenix, United States
- Banner Sun Health Research InstituteVerified postcodeSun City, United States
- UCI MINDVerified postcodeIrvine, United States
- University of Southern CaliforniaVerified postcodeLos Angeles, United States
- Hoag Memorial Hospital PresbyterianVerified postcodeNewport Beach, United States
- Stanford UniversityVerified postcodePalo Alto, United States
- Sharp Mesa Vista HospitalVerified postcodeSan Diego, United States
- University of California, San FranciscoVerified postcodeSan Francisco, United States
- University of California, DavisVerified postcodeWalnut Creek, United States
- Yale University School of MedicineVerified postcodeNew Haven, United States
- Georgetown UniversityVerified postcodeWashington D.C., United States
Common questions
What is 'preclinical Alzheimer's disease'?
This means you have very early signs of Alzheimer's in your brain, like protein build-up, but you don't have any memory problems or changes that affect your daily life yet.
What is amyloid, and why is it important?
Amyloid is a protein that can build up in the brain and is a key feature of Alzheimer's disease. Researchers believe reducing it might help slow down the disease process.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It's used to compare the effects of the active medicine fairly.
What does 'Phase 3' mean for a study?
Phase 3 is a large study involving many people. It's done after earlier smaller studies show promise, to confirm if a new treatment is effective, safe, and better than existing options or a placebo.
Will I know if I'm getting the actual medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know who is receiving the active medicine and who is receiving the placebo. This helps ensure the results are unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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