A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
This research study is investigating a new medication called donanemab for individuals in the early stages of Alzheimer's disease. Researchers are looking to understand if donanemab is safe to use and whether it can help improve or slow down the progression of memory and thinking problems associated with the condition. Participants will either receive the study medication or a dummy treatment (placebo). The study will last for up to 93 weeks, including initial checks and follow-up appointments. This is a "Phase 3" trial, which means it's a large study designed to gather more definitive information on the treatment's effectiveness and safety before it could potentially be made widely available.
At a glance
What is this study about?
This study, called TRAILBLAZER-ALZ 5, is focused on a new medication called donanemab. It's designed for people who are in the early stages of Alzheimer's disease – that means individuals who might be experiencing mild memory or thinking difficulties but are still able to carry out their daily activities. The main goal is to find out if donanemab can be a safe and effective treatment to help manage these symptoms and potentially slow down the disease's progression.
Alzheimer's disease is a common cause of dementia, affecting memory, thinking, and behaviour. Scientists believe that a substance called amyloid builds up in the brains of people with Alzheimer's. Donanemab works by targeting and helping to clear away this amyloid. By studying its effects on people with early Alzheimer's, researchers hope to see if removing amyloid can make a real difference in how the disease develops.
Participants in this study will either receive donanemab or a placebo, which looks like the real medication but doesn't contain any active drug. This is a common way to test new treatments fairly, as it helps researchers understand the true effects of the medication. The study is "double-blind," meaning neither the participants nor their doctors will know who is receiving which treatment until the study is over. This helps ensure the results are unbiased and reliable.
Key takeaways
- The study tests a new medication, donanemab, for early Alzheimer's disease.
- It aims to see if donanemab is safe and can improve memory and thinking.
- You would receive either donanemab or a placebo, not knowing which.
- A dedicated 'study partner' is essential for participation.
- The study involves regular visits and assessments over approximately two years.
- Participation could help advance understanding and treatment of Alzheimer's.
Who may be eligible?
To join this study, generally, you'd need to be between 60 and 85 years old and have had a gradual and ongoing change in your memory that you or someone close to you has noticed for at least six months. Your doctor would check your memory and thinking skills to see if they fit the study's requirements. You would also need to have certain patterns of a substance called amyloid in your brain, which is a key indicator of Alzheimer's disease.
A really important part of this study is having a "study partner" – this is someone who knows you well and spends at least 10 hours a week with you. They would need to agree to be involved, help you attend appointments, and be available to answer questions about your memory and daily activities. This is because their observations are crucial for understanding how the treatment might be affecting you.
You wouldn't be able to join if you have other significant brain conditions like Parkinson's disease, or other serious health problems that might complicate the study or make it unsafe for you. Also, generally, you'd need to be taking any current medications for your memory or thinking problems in a stable way for about a month before starting the study.
- Are you between 60 and 85 years old?
- Have you noticed a gradual change in your memory for at least six months?
- Do you have a close family member or friend who could be your 'study partner' and commit to supporting you?
- Do you have no other major neurological conditions like Parkinson's disease?
- Are your current medications for memory or thinking stable for about a month?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to see if you meet all the requirements. This would involve various health checks, memory assessments, and brain scans. Once accepted, you would be assigned to either receive the study medication (donanemab) or a dummy treatment (placebo) – you and your doctor wouldn't know which one.
The study treatment would be given through regular infusions, and you'd have appointments over a period of up to 93 weeks (about a year and nine months). These appointments would include physical examinations, blood tests, and detailed assessments of your memory and thinking skills. Your study partner would also need to be present or available by phone for certain assessments, as their input is very important.
Regular follow-up appointments would continue even after the main treatment phase to monitor your health. The total time commitment, from your first screening visit to the final follow-up, could be almost two years. All travel costs and expenses related to your participation would typically be covered.
Potential risks and benefits
Locations (141)
- Hospital Italiano de Buenos AiresABB, Argentina
- Clinica Privada BanfieldBanfield, Argentina
- Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)Buenos Aires, Argentina
- Stat Research S.A.Buenos Aires, Argentina
- Centro de Investigaciones Metabólicas (CINME)Buenos Aires, Argentina
- CIPRECBuenos Aires, Argentina
- Mautalen Salud e InvestigaciónBuenos Aires, Argentina
- Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, Argentina
- Centro Médico ArsemaBuenos Aires, Argentina
- Instituto Geriatrico Nuestra Señora de Las NievesBuenos Aires, Argentina
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)Buenos Aires, Argentina
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)Buenos Aires, Argentina
+129 more sites — see the official record for the full list.
Common questions
What is Alzheimer's disease?
Alzheimer's disease is the most common cause of dementia, a condition that gradually affects memory, thinking, and daily activities. It's caused by changes in the brain.
What is donanemab?
Donanemab is a new medication being tested. It's designed to target and help remove a specific protein called amyloid, which is believed to build up in the brains of people with Alzheimer's disease.
What does 'early symptomatic Alzheimer's disease' mean?
This refers to people who are starting to experience mild memory or thinking problems due to Alzheimer's disease, but who can still manage most of their daily tasks. It includes what doctors call 'prodromal AD' and 'mild dementia due to AD'.
Why do I need a 'study partner'?
A study partner, like a close family member or friend, is important because they can provide valuable insights into your daily memory and thinking, which helps researchers understand how the treatment might be affecting you. They also help with practical support.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real study medication but contains no active drug. It's used to compare against the active medication to see if the real drug is truly effective.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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