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)

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)

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 50 - 100 Status: Completed
Time Since Diagnosis: Less than 60 years Study Focus: Cognitive Deficits

Study Purpose:

The purpose of this study placebo-controlled, randomized, double-blind study is 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.

More Details

This study includes a Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period. Final eligibility will be determined at the Baseline Visit. Eligible patients will be randomized to receive placebo or SYN120 100 mg once a day (QD).

Phase: Phase 2 Lead Sponsor: Biotie Therapies Inc.
Trial ID: 003985 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors: Michael J. Fox Foundation for Parkinson's Research, Parkinson's Study Group, Massachusetts General Hospital
Estimated Enrollment: 80 Study Start Date:
Estimated Study Completion Date: December 2017 Source: ClinicalTrials.gov
Study Website:
This is a FDA Regulated Trial

More Inclusion & Exclusion Criteria

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