Clinical Trials

There are no FDA-approved therapies currently available for ALSP. Supportive therapies to treat the symptoms of ALSP may include therapies that are approved for other neurological conditions.

Read below for more information on available clinical trials and how you and your patients can become involved in important scientific research for ALSP.

ILLUMINATE (ClinicalTrials.gov identifier, NCT05020743) is a natural history study designed to learn more about how ALSP occurs and how the disease affects individuals over time. Study participants will not receive any investigational drugs as part of this study and will continue their standard of care treatment during the study. Vigil Neuroscience is developing an investigational drug, iluzanebart (VGL101), to treat people with ALSP. The goal of ILLUMINATE is to provide information that may help with the development of future treatments for ALSP, including iluzanebart. Enrollment in this study will not impact participants’ eligibility to enroll in the IGNITE study of the investigational drug iluzanebart for the treatment of ALSP.

IGNITE (ClinicalTrials.gov identifier, NCT05677659) is a multicenter, open-label, phase 2 trial to assess the safety and tolerability of iluzanebart (VGL101) in patients with documentation of a mutation in the CSF1R gene for the treatment of ALSP and to evaluate the effects of iluzanebart on brain imaging, biomarkers, and signs and symptoms of ALSP disease progression.

More information on ILLUMINATE or IGNITE can be found at
www.clinicaltrials.gov and www.alspstudy.com.