This study will assess iluzanebart (VGL101), a new potential therapy for ALSP. The study will look at the safety of iluzanebart as treatment for ALSP and will also measure the effect of the treatment on the symptoms of ALSP.
If you would like more information on the study, we'd love to hear from you.
Who are the participants?
Each person meets the following main inclusion criteria:
- 18 years of age or older
- Documentation of a gene variant in the CSF1R gene
- Having clinical symptoms of ALSP
- Has a study partner (caregiver, friend, family member, etc.) who will commit to supporting throughout the study
*There are additional inclusion and exclusion criteria for this study.
Where will the study take place?
The study will have sites in the following countries.
United States
France
Germany
Netherlands
United Kingdom
View the study listing for additional details on study sites and eligibility criteria
Study purpose
The study will evaluate iluzanebart (VGL101) for the treatment of ALSP with the following goals
Safety and Tolerability
The main objective is to evaluate how safe the treatment is and how potential side effects are tolerated.
Brain Imaging and Biomarkers
Magnetic resonate imaging (MRI) of the brain and other tests will measure the effects of iluzanebart (VGL101) on disease severity and progression.
Signs and Symptoms
Cognition, motor skills, and other symptoms will be assessed to measure changes in ALSP symptoms.
Overview of study participation
Study participation will last approximately 60 weeks (around 14 months)
Participants will travel to the study site to receive treatment and participate in assessments to evaluate the study treatment. Study visits will take place about every 4 weeks (around 15 visits total).
Participants will receive treatment with iluzanebart (VGL101) approximately every 28 days during the study. The treatment will be given during clinic visits via an intravenous (IV) infusion lasting about 1 hour.
Vigil Neuroscience believes that study participation should not require a financial investment to the participant. Travel assistance and stipends for participation may be available to participants and caregivers.
Before starting the study, participants (or a partner/guardian) will receive an overview of study details in an informed consent form. It is important to make an informed decision to participate in any clinical study. Interested participants are encouraged to ask questions about the study purpose, schedule, potential risks or benefits, and other topics.
Interested in learning more?
View the study listing and additional details including study sites and eligibility criteria
Explore resources to facilitate ongoing learning about the study as well as support for individuals and families with ALSP.
If you'd like more information, we'd love to hear from you.