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:
- ≥ 50 years old
- Diagnosis of probable PDD
- Stable regimen of cholinesterase inhibitor for ≥12 wks
- Stable regimen of PD medication for at least 4 weeks prior to Baseline
- Contact with a responsible caregiver ≥3 days/wk
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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