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

Phase 2

Completed

• Conditions: Parkinson's Disease Dementia (PDD)
• Interventions: Drug: Placebo; Drug: SYN120

• Registration Number: NCT02258152
• Lead Sponsor: Biotie Therapies Inc.

Brief 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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Study Start: 2014-12-22
• Primary Completion: 2017-10-03
• Study Completion: 2017-10-03
• Results First Submitted: 2018-09-14
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Results First Posted: 2019-04-19
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SYN120	SYN120	-

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Objective of This Study is to Assess the Efficacy of SYN120 on Cognition as Determined by the Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention in Patients With Parkinson's Disease.	up to Week 16	To access the effect of SYN-120 for Continuity of Attention, a measure which reflects the ability to sustain attention and avoid error The Cognitive Drug Research Computerized Cognition Battery is a computerized neuropsychological test battery to assess cognitive tasks based on measures of Vigilance (1 - 180 seconds) and Choice Reaction Time (1 - 120 seconds). The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test.; The ability to keep mind on a single task over time. COA is calculated as (VIGACC\*0.45) + (CRTACC\*0.5) - where VIGACC is digit vigilance accuracy, CRTACC is choice reaction time accuracy. Higher COA scores represent greater sustained attention and avoidance of errors.

Secondary Outcome Measures

Name	Time	Method
To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)	up to Week 16	To access the effects of SYN120 for Quality of Episodic Memory. QEM measures the ability to store, hold, and retrieve information of an episodic nature. The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test.; Quality of Episodic Memory is calculated as (DRECOACC + DRECNACC - 100) + (DPICOACC + DPICNACC - 100) +((IRCL - IRCLERR)\*100 / 15) + ((DRCL - DRCLERR)\*100 / 15), where DRECOACC is Word Recognition original stimuli accuracy (1 - 120 seconds), DRECNACC is word recognition new stimuli accuracy, DPICOACC is Picture Recognition original stimuli accuracy (1 - 120.5 seconds), DPICNACC is picture recognition new stimuli accuracy, IRCL is Immediate Word Recall (1 - 120.5 seconds), IRCLERR is immediate word recall errors, DRCL is Delayed Word Recall (1 - 120.5 seconds), and DRCLERR is delayed word recall errors. Higher QEM scores greater ability to retain memory.

Trial Locations

Locations (20)

Northwestern University, Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Parkinson's Disease Movement Disorder Center; 🇺🇸 Philadelphia, Pennsylvania, United States

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

UC San Diego; 🇺🇸 La Jolla, California, United States

Parkinson's Disease & Movement Disorder Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

University of Iowa, Carver College of Medicine; 🇺🇸 Iowa City, Iowa, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

Struthers Parkinson's Center; 🇺🇸 Golden Valley, Minnesota, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center; 🇺🇸 Baltimore, Maryland, United States

Atlantic Neuroscience Institute; 🇺🇸 Summit, New Jersey, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Wake Forest Baptist Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Baylor Univeristy; 🇺🇸 Houston, Texas, United States

Houston Methodist Neurological Institute/Movement Disorders Clinic; 🇺🇸 Houston, Texas, United States

Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States