Two ALSP Studies Now Recruiting

The ULF is happy to share this information on behalf of Vigil Neuro. Contact information is listed below for more information.

Natural History Study in Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia (ALSP)

• ClinicalTrials.gov ID NCT05020743
• Sponsor Vigil Neuroscience, Inc.
• Key Inclusion Criteria for Definitive ALSP patients, only:
  • 1. Subjects who fulfill both of the following criteria (a and b):
    • a. More than two findings of clinical signs or symptoms in the following categories: i. Cognitive impairment or psychiatric problem ii. Pyramidal signs on neurological examination iii. Extrapyramidal signs, such as rigidity, tremor, abnormal gait, or bradykinesia iv. Epilepsy b. MRI findings consistent with ALSP: specifically, bilateral cerebral white matter lesions with or without thinning of the corpus callosum NOTE: Subjects with other causes of leukoencephalopathy, including vascular dementia, multiple sclerosis, or leukodystrophy (e.g., adrenoleukodystrophy, Krabbe disease, metachromatic leukodystrophy), will be excluded.
  • 2. Subjects who, in the investigator’s opinion, have demonstrated clinical progression of their ALSP within the past year.
  • 3. Subjects who meet the criteria for definitive ALSP must have a designated caregiver who spends at least 4 hours per week with them. The caregiver must be able and willing to assist the subject in complying with the study requirements, be able to provide information during study visits, and be willing to sign a caregiver ICF.

A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia

• ClinicalTrials.gov ID NCT05677659
• Key Inclusion Criteria:·
  • Participants who have documentation of a gene mutation in the CSF1R gene
  • Participants fulfill both (Parts A and B) of the following criteria:
    • 1. The participant has more than 2 findings of clinical signs or symptoms in the following categories:
      • 1. Cognitive impairment or psychiatric problem
      • 2. Pyramidal signs on neurological examination
      • 3. Extrapyramidal signs, such as rigidity.
      • 4. Epilepsy
    • 2. MRI findings consistent with ALSP, specifically, bilateral cerebral white matter lesions with or without thinning of the corpus callosum, on the Screening MRI.
  • The participant must have a study partner (i.e., caregiver, family member, friend, etc.) who, in the investigator’s judgment, has frequent and sufficient contact with the subject so as to be able to provide accurate information about the participant’s health and cognitive and functional abilities. The study partner must be willing to sign a study partner ICF.

If you are interested in learning more, please reach out to: