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

Enrolling By Invitation
55 years - 89 years
All
Phase 2
8 participants needed
1 Location

Brief description of study

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.

Eligibility of study

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

  • Conditions: Alzheimers Disease
  • Age: 55 years - 89 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 829920
If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

 

Interested in the study?

Message For Enrolling By Invitation Trial

study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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