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

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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:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Massachusetts General Hospital
Acorda Therapeutics
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dementia (PDD) Drug: SYN120 Drug: Placebo Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 22, 2014
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo QD

Experimental: SYN120 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).




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258152


  Show 20 Study Locations
Sponsors and Collaborators
Biotie Therapies Inc.
Michael J. Fox Foundation for Parkinson's Research
Massachusetts General Hospital
Acorda Therapeutics
Investigators
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Study Director: Christopher Kenney Acorda Therapeutics
  Study Documents (Full-Text)

Documents provided by Biotie Therapies Inc.:
Study Protocol  [PDF] April 14, 2016
Statistical Analysis Plan  [PDF] November 15, 2017


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Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT02258152     History of Changes
Other Study ID Numbers: SYN120-CL03
First Posted: October 7, 2014    Key Record Dates
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019
Last Verified: April 2019
Keywords provided by Biotie Therapies Inc.:
PDD
Parkinson's Disease Dementia
patients taking a cholinesterase inhibitor.
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders