Phase II Study to Assess the Safety Tolerability and Target Engagement of AMX0035 a Fixed Combination of Sodium Phenylbutyrate and Tauroursodeoxycholic Acid for the Treatment of Alzheimers Disease

  • STATUS
    Enrolling By Invitation
  • participants needed
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Updated on 19 February 2024

Summary

This is a double blind, randomized, placebo controlled trial in subjects with mild cognitive impairment or dementia due to Alzheimer's disease (AD). AMX0035 is a combination of two compounds, Sodium Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA) that are hypothesized to prevent neuronal death through distinct pathways. AMX0035 is not approved by the FDA. Treatment duration is 24 weeks. The trial will enroll subjects who are between 55 and 89 inclusive and must have a diagnosis of "Probable Alzheimer's Disease" or Mild Cognitive Impairment with a primarily amnestic presentation (deficit in learning and recall of recently learned information) that is accompanied by the presence of documented biomarkers (amyloid PET, CSF AD biomarkers, FDG-PET, or vMRI) supporting that the syndrome is likely due to AD pathology. An MRI scan is required at screening or baseline and again at Week 24. 2 lumbar punctures to collect Cerebral Spinal Fluid are required at screening and Week 24.

Details
Condition Alzheimers Disease
Age 55years - 89years
Clinical Study Identifier03533257
Last Modified on19 February 2024

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