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

• ClinicalTrials.gov Identifier: NCT02258152
• Recruitment Status: Completed
• First Posted: October 7, 2014
• Results First Posted: April 19, 2019
• Last Update Posted: April 19, 2019
• Sponsor: Biotie Therapies Inc.
• Collaborators: Michael J. Fox Foundation for Parkinson's Research; Massachusetts General Hospital; Acorda Therapeutics
• Information provided by (Responsible Party): Biotie Therapies Inc.

Tracking Information

• First Submitted Date: October 3, 2014
• First Posted Date: October 7, 2014
• Results First Submitted Date: September 14, 2018
• Results First Posted Date: April 19, 2019
• Last Update Posted Date: April 19, 2019
• Actual Study Start Date: December 22, 2014
• Actual Primary Completion Date: October 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2019)

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. [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: October 6, 2014): Change in Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention from baseline [ Time Frame: Week 16 ]

Current Secondary Outcome Measures (submitted: April 17, 2019)

To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM) [ Time Frame: 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
• Official 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)
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Parkinson's Disease Dementia (PDD)

Intervention

• Drug: SYN120
  SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
• Drug: Placebo
  Placebo QD

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: SYN120
  Intervention: Drug: SYN120

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 6, 2018): 82
• Original Estimated Enrollment (submitted: October 6, 2014): 80
• Actual Study Completion Date: October 3, 2017
• Actual Primary Completion Date: October 3, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02258152
• Other Study ID Numbers: SYN120-CL03
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Biotie Therapies Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Biotie Therapies Inc.
• Original Study Sponsor: Same as current

Collaborators

• Michael J. Fox Foundation for Parkinson's Research
• Massachusetts General Hospital
• Acorda Therapeutics

Investigators

• Study Director: Christopher Kenney; Acorda Therapeutics

• PRS Account: Biotie Therapies Inc.
• Verification Date: April 2019