Northwestern University Feinberg School of Medicine

Parkinson's Disease and Movement Disorders Center

Synapse Study: Efficacy, Safety, and Tolerability of SYN120 in Parkinson’s Disease Dementia

Study Title: 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)

Funded by:Biotie Therapies, Inc.

Clinical Trial Investigator Name: Tanya Simuni, MD

Clinical Trial Description:

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-arm, 16-week study in PDD patients taking a cholinesterase inhibitor. Eligible patients will be randomized to receive placebo or SYN120 100 mg QD in a ratio of 1:1.

The primary efficacy objective of this study is to assess the efficacy of a fixed dose of SYN120 on cognition as determined by the Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention in patients with PDD treated with a stable dose of a cholinesterase inhibitor.

Clinical Trial Eligibility Criteria:

Research Study Visits: 24 weeks – includes six visits and two telephone interviews

Treatment: SYN120 (100 mg once a day, orally) or Placebo

Compensation: Parking voucher for NM designated parking garages

IRB Project #: STU00020019

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