A Study to Evaluate SYN120's Safety, Tolerability and Efficacy in Parkinson's Disease Dementia

What we are studying

The purpose of this research study is to find out if SYN120 can be safely given to patients with Parkinson’s disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor (i.e. Aricept, Exelon, Cognex, Razadyne, or Namzaric) and to see if SYN120 helps to improve cognition (also known as your ability to think, understand, learn, and recall). We also want to find out if SYN120 can improve your ability to remember past personal events (also known as episodic memory).

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 50+

Eligibility Criteria

  • Inclusion Criteria:
    • - Diagnosed with Parkinson's Disease Dementia -Patient has a routine caregiver -Taking a stable cholinesterase inhibitor (i.e. Aricept
  • Exelon
  • Cognex
  • Razadyne
  • Or Namzaric). -Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive Exclusion Criteria:
    • -History of any significant neurologic or psychiatric disease other than PD -Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study -Unpredictable motor fluctuations that would interfere with administering assessments

What is involved

  • You will be in the study for about 6 months (24 weeks)
  • Up to 6 weeks in screening
  • A 16 week dosing period and a 2 week safety follow-up period. During this time
  • We will ask you to make 6 visits to the hospital (including the Screening visit) and complete 2 telephone interviews during the study. If you are enrolled in the study
  • You will be asked to take 2 pills once a day throughout the 4 month (16 weeks) dosing period. Study assessments include: physical and neurological exams
  • Vitals
  • Blood and urine samples
  • Questionnaires
  • And cognitive testing.

Compensation

None

Contact Information

Study Coordinator
Jessica Dimos
Email
jdimos@wakehealth.edu
Phone
336-716-8694
Principal Investigator
Mustafa Siddiqui, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.