Early-Phase Study of NPC-1 Treatment for Alzheimers Disease Biomarkers in Adults Aged 55 and Older

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effects of a natural product combination called NPC1, which includes parthenolide and ipriflavone, on blood biomarkers related to Alzheimers disease in adults. The trial focuses on people aged 55 and older who have subjective cognitive decline, mild cognitive impairment, or Alzheimers disease with evidence of disease-related changes in their blood. This early phase, open-label, single-arm study aims to understand how NPC1 impacts key indicators of Alzheimers pathology. During the trial, participants will undergo a lead-in observational period without intervention, followed by an active treatment phase where they receive NPC1. Researchers will collect blood samples before and after treatment to measure several Alzheimers-related biomarkers such as plasma p-tau217, glial fibrillary acidic protein, neurofilament light chain, and abeta42abeta40 ratios. The study also monitors safety and tolerability of the NPC1 treatment over six months. Participants will be involved for at least six months, during which they will provide serial blood samples for biomarker analysis and have their health and cognitive status monitored. A study partner who interacts regularly with the participant will help provide information on cognition and daily functioning. The main outcomes include changes in blood biomarkers and assessment of NPC1s safety. The study includes regular clinical assessments and screening for depression and other health conditions to ensure participant well-being throughout the trial.

Biomarker-based Trial of NPC-1 for Alzheimer's Pathology