SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

• Status: Completed
• Trial end date: 2017-10-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotie Therapies Inc.
• Collaborators: Acorda Therapeutics; Massachusetts General Hospital; Michael J. Fox Foundation for Parkinson's Research; Parkinson's Study Group
• Treatments: Serotonin 5-HT2 Receptor Antagonists

Criteria

Inclusion Criteria:

• Parkinson's Disease Dementia

• Patient has a routine caregiver

• Taking a stable cholinesterase inhibitor.

• 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