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

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.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Alzheimers Disease
• Age: Between 55 Years - 89 Years
• Gender: All