A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

This study is open to adults of any age (18 years and older) who are male or female. The key is that you must either be at risk of developing frontotemporal dementia (FTD) or have already been diagnosed with FTD.

Crucially, your FTD or risk of FTD must be linked to a specific genetic change, called a 'mutation', in a gene named progranulin. This is a very specific type of FTD, so testing for this gene change will be an important part of checking if you can join the study.

There might be other specific health requirements or conditions that would mean you couldn't take part, to ensure the study is safe for everyone and that the results are clear. Your doctor will be able to discuss all the detailed criteria with you.

If you decide to take part in this study, you will be given either the new medicine, latozinemab, or a 'dummy' treatment (placebo). You will receive this treatment through a drip into your arm (intravenous infusion). Neither you nor your study doctor will know whether you are receiving the active medicine or the placebo, which is called 'double-blind' and is standard practice in medical studies to ensure fair results.

You will need to attend regular appointments at the study clinic over a period of at least two years. These visits will involve various tests to check your memory, thinking skills, and general well-being. This will include special assessments that look at how FTD affects daily life. Doctors and nurses will also monitor your health closely and look for any side effects from the medication.

Your participation will involve several visits over approximately 96 weeks (about two years). There will also be follow-up appointments after you stop receiving the study medicine to ensure your continued safety and to see how you are doing.