SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
Purpose: To assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.
Duration: Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period.
Study Design: Randomized, Double Blind
50 Years and Older
Parkinson's Disease Dementia
Patient has a routine caregiver
Taking a stable cholinesterase inhibitor.
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