The CELIA clinical trial (Biogen 247AD201)
Participant type
Overview
This study is no longer looking for new participants but is still ongoing.
The CELIA clinical trial is researching a potential treatment for people with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia by focusing on a protein called tau. Abnormal tangles of built-up tau protein can be considered a key sign of the disease. We want to understand if different doses of a study medication called BIIB080 could be safe and have an effect on the progression of Alzheimer’s disease.
Summary
What is the study about?
The CELIA clinical trial is researching a potential treatment for people with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia by focusing on a protein called tau. Abnormal tangles of built-up tau protein can be considered a key sign of the disease.
Today, Alzheimer’s disease research focuses on the role of two proteins in the brain that don’t work like they should:
- Plaques: Beta-amyloid fragments cluster together into larger deposits called amyloid plaques. The plaques appear to have a toxic effect on neurons (nerve cells), which stops messages passing from one cell to another.
- Tangles: Tau proteins change shape and form tangles inside neurons—commonly known as tau tangles— compromising the normal function and health of neurons.
When neurons are damaged the brain cannot send messages as easily. This can cause some of the symptoms of Alzheimer’s disease like confusion, forgetfulness, and behaviour changes. Other treatment research for Alzheimer’s disease focuses on targeting amyloid plaques.
What are you trying to find out?
The CELIA trial is researching a study medication that aims to reduce the production of tau in order to understand if it could have an effect on the progression of Alzheimer’s disease, potentially slowing down symptoms of the disease.
We want to understand if different doses of a study medication called BIIB080 could have side effects and potentially delay disease progression in people with Alzheimer’s disease.
What does taking part involve?
This study is no longer looking for new participants but is still ongoing.
Your participation in the study will last for 105 weeks (about 2 years) in total. During your participation, you will have up to 18 study site visits and up to 15 follow-up telephone calls. The study will have 3 periods:
- Screening period (about 9 weeks): The screening period involves some assessments to understand if the CELIA trial could be a good fit.
- Treatment period (76 weeks or approximately 18 months): During the placebo-controlled treatment period, you will go to study visits to receive either the study medication or placebo once every three months. You and your care partner will also receive scheduled follow-up phone calls.
- Follow-up period (20 weeks or 5 months): The follow-up period includes one study centre visit and one phone call to check on your health.
If you qualify and choose to join the CELIA trial, you will be randomly (by chance) assigned to a study group in which you will receive either the study medication or placebo. Neither you, your care partner, nor the study team will know which group you are in. You will receive seven doses of your assigned dose of study medication or placebo.
Who is it for?
This study is no longer looking for new participants but is still ongoing.
To join this trial, volunteers must:
- Have been diagnosed with mild cognitive impairment due to Alzheimer’s disease OR mild Alzheimer’s disease dementia
- Be 50 to 80 years old
- Have a care partner (sometimes called a study partner) who agrees to support them throughout the trial.
Other criteria apply and your study team will explain these to you.
Why is it important?
Your participation could help advance Alzheimer’s disease research for yourself, your community, and people around the world.
How can I find out more?
This study is no longer looking for new participants but is still ongoing.
However, if you have questions for the research team, click the button below to email us:
Meet the researcher
Ross DunneLater Life Psychiatrist and Dementia Specialist
I'm Ross Dunne, a later life psychiatrist and dementia specialist working in GMMH. I am also the clinical director of the Greater Manchester Dementia Research Centre, the region's leading clinical trial unit for the diseases causing dementia. My research focusses on simpler ways to diagnose the underlying causes of dementia, and assessing treatments to help slow dementia or improve symptoms.