Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to measure changes in cognition through verbal and visual test procedures
      and changes in biomarkers of Alzheimer's disease and inflammatory and metabolic parameters
      that can be measure in the central nervous system (CNS) with advanced neuroimaging techniques
      in patients treated with NE3107 (17a-ethynyl-androst-5-3b,7b,17b-triol).
    

Detailed description: 
      Considering how many people are in a state of mild cognitive impairment (MCI) and frank
      dementia, there is a substantial cost to society in terms of financial burden and suffering.
      Degenerative conditions that result in cognitive change in middle and late life are
      frequently associated with abnormal deposits of protein material (e.g., amyloid, phospho-tau)
      which interfere with neuronal function and viability. Inflammation and insulin resistance in
      the CNS and abnormal protein deposition and resultant physiological impairment characterize
      conditions of the Alzheimer's dementia (AD) type.

      Neuroinflammation prompts AD progression, impaired cholesterol efflux and reduced insulin
      signaling (insulin resistance). Insulin resistance has been considered a risk factor as well
      as a feature of AD, and has also been associated with increased aß-42 secretion, neuritic
      plaque burden, abnormal insulin receptor performance, decreased glucose metabolism, and
      consequently decreased cognitive performance.

      No therapy exists that has been proven to halt or reverse the progressive deposition of
      abnormal proteins or the attendant neurophysiological deterioration. Various investigational
      therapies aim to target the pathophysiological processes of AD; from combating abnormal
      protein deposition, to targeting sources of systemic and neuroinflammation, to providing
      cholinergic, hormonal, and metabolic support. A promising area of research is the ongoing use
      of insulin synthesizers as a therapeutic option for AD.

      Several Phase 3 studies have been initiated and/or completed with compounds such as
      Semaglutide, a hormone that stimulates insulin signaling, Metformin, an insulin synthesizer,
      and NE3107, an anti-inflammatory insulin-sensitizing agent.

      This study seeks to measure changes in cognition through verbal and visual test procedures
      and changes in biomarkers of Alzheimer's disease and inflammatory and metabolic parameters
      that can be measured in the CNS with advanced neuroimaging techniques in patients treated
      with NE3107 (17a-ethynyl-androst-5-ene-3b,7b,17b-triol).

      Investigational Product

      The drug under investigation is NE3107 (17a-ethynyl-androst-5-ene-3b,7b,17b-triol). NE3107 is
      formulated with common excipients used in oral medications in #2 hard gelatin capsules. The
      capsules are designed for oral administration. NE3107 capsules are stable at room temperature
      for at least 18 months. Stability of the capsules used in this study will be monitored by a
      concurrent stability study conducted by the capsule manufacturer and the holder of the
      primary IND, Biovie, Inc (Santa Monica, CA).
    

Intervention name(s): NE3107
Intervention type(s): Drug
Intervention description(s): Participants will take 20mg twice daily (BID) approximately 12 hours apart. The dose will be stable the duration of the study intervention (3 months)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment