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

Terminated
Conditions
ALSP
Registration Number
NCT05020743
Lead Sponsor
Vigil Neuroscience, Inc.
Brief Summary

Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) is a rare, rapidly progressing, genetic, neurodegenerative disease for which no definitive treatment options and limited information on the natural history of the disease are available. The structural, genetic, and neuropathophysiological abnormalities of ALSP lead to the onset of neurologic symptoms, such as moderate to severe motor and neuropsychiatric impairments. This natural history study will collect data to contribute to the development of future novel therapies that focus on the neuropathophysiological features that underlie ALSP and that are essential to reverse, delay, or stop progression of this debilitating disorder.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
56
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Magnetic Resonance Imaging (MRI)Months 6, 12, 18, 24, 30, and 36 Months

Change from Baseline in structural and volumetric MRI

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (12)

Investigative Site 4

🇺🇸

San Francisco, California, United States

Investigative Site 5

🇺🇸

Englewood, Colorado, United States

Investigative Site 1

🇺🇸

Boca Raton, Florida, United States

Investigative Site 2

🇺🇸

Jacksonville, Florida, United States

Investigative Site 11

🇺🇸

Boston, Massachusetts, United States

Investigative Site 10

🇺🇸

Philadelphia, Pennsylvania, United States

Investigative Site 12

🇧🇷

São Paulo, Brazil

Investigative Site 3

🇨🇦

London, Ontario, Canada

Investigative Site 8

🇩🇪

Leipzig, Germany

Investigative Site 9

🇩🇪

Tübingen, Germany

Scroll for more (2 remaining)
Investigative Site 4
🇺🇸San Francisco, California, United States

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