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Phase II-III

Trial of Amlenetug in Patients with Multiple System Atrophy (MASCOT)

  • Study HIC#:2000038056
  • Last Updated:11/24/2025

The MASCOT Trial aims to see if the investigational trial drug (Lu AF82422) is effective and safe in slowing the disease progression in people living with multiple system atrophy (MSA). The clinical trial will compare the investigational trial drug to a placebo (inactive medication). The investigational trial drug is given by intravenous (IV, or though a vein) infusion once every 4 weeks.

MASCOT | A Clinical Research Trial

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      Trial Purpose and Description

      This 12-week double-blind, randomized, placebo-controlled trial aims to assess the effect of MitoQ on neurocognition, psychiatric symptoms, functioning, and exosomal biomarkers (miR-137 and COX6A2) in individuals with early-phase schizophrenia-spectrum disorders (E-SSD). Conducted at Yale University and McLean Hospital/Harvard Medical School, the study will involve 50 participants at Yale, stratified into high risk (HR) and low risk (LR) groups based on mitochondrial dysfunction markers. The primary objective is to evaluate changes in global cognition using the MATRICS Consensus Cognitive Battery (MCCB). Secondary objectives include assessing changes in clinical outcomes (GAF, SOFAS, PANSS) and blood biomarkers. The hypothesis is that MitoQ will improve cognitive function, particularly in the HR subgroup with mitochondrial dysfunction.

      Eligibility Criteria

      Eligibility Criteria

      • 40-75 years of age
      • Have been diagnosed with MSA and it has been less than 5 years from the time of onset of MSA symptoms related to abnormal body movement
      • Have a reliable caregiver who will be available throughout the trial to complete caregiver observer questionnaires

      Principal Investigator

      Sub-Investigators

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