A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD
Condition: Parkinson's Disease, Idiopathic
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules
      compared with placebo capsules in participants with early PD.

      Study details include:

        -  The study duration will be up to 7-8 months.

        -  The double-blind treatment duration will be up to 6 months.

        -  There will be 5 in-clinic visits and 7 phone calls
    

Detailed description: 
      450 early Parkinson's Disease (PD) patients will be randomized to 10mg, 20 mg of
      buntanetap/posiphen or placebo. They will undergo a Screening Visit, and if they provide
      informed consent and are considered eligible per the inclusion and exclusion criteria, will
      proceed to participate in the treatment period. Randomized participants will visit the clinic
      for the first-time dosing in clinic with administration of 10 mg or 20mg of
      buntanetap/posiphen or placebo, followed by an at home dosing period of 6 months, with daily
      administration of 10 mg or 20mg of buntanetap/posiphen or Placebo. Participants will be
      required to visit clinics 1 month, 2 months, 3 months, and 6 months (end-of-trial), where
      they will undergo study procedures that include safety assessments (AE and concomitant
      medication monitoring, 12-lead ECGs, clinical laboratory testing, vital signs assessments,
      and physical examinations) and psychometric tests (MDS-United Parkinson's Disease Rating
      Scale (MDS-UPDRS), Clinical Global Impression of Severity (CGIS), Wechsler Adult Intelligence
      Scales (WAIS), Mini-Mental State Examination (MMSE)) and Participant Global Impression of
      Change (PGIC). At the end of blood sampling, the subjects will need to stay for a minimum of
      1 hour of observation. After all end-of-study procedures are complete, the subject will be
      discharged to home. A 24-hour follow-up call will occur after all clinical visits to assess
      the participants current condition and if there are any additional adverse events to report.

      Buntanetap/posiphen has shown to improve PD subjects' mobility. MDS-UPDRS sum of score of
      Part II + Part III and Total score of all four parts will be measured to assess its
      improvement on PD subjects daily living, mobility and complications. PGIC will also be
      measured to assess its effect.

      Buntanetap/posiphen has shown to reduce inflammation and preserve axonal integrity and
      synaptic functions as well as neurotoxic proteins in previous Phase 2a studies. In this study
      we plan to measure plasma GFAP, NFL and potentially TDP43.

      Reports of adverse events (AEs) and serious adverse events (SAEs) during exposure to
      buntanetap/posiphen will be collected to evaluate if there are any significant clinical
      safety issues for the study population. Extensive clinical and laboratory safety data already
      exist for buntanetap/posiphen; therefore, these safety measures will be sufficient in the
      proposed study.

      For clinical, functional, and cognitive assessment measures, The subjects will be
      administered the Hoehn & Yahr and the MMSE for determination of inclusion into the study. The
      MDS-UPDRS and PGIC will be administered for subjects' movement and daily function. The Coding
      subtest from the WAIS 4th edition will serve as a sensitive measure of Central Nervous System
      (CNS) dysfunction. MMSE will also be measured to assess subjects' cognitive change.
    

Intervention name(s): buntanetap/posiphen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HPMC (vegetarian source) capsule shells; HPMC (vegetarian source) capsule shells
Other intervention name(s): Posiphen Tartrate; ANVS401
Intervention MeSH terms: Phenserine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's