SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) (SYNAPSE)
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| ClinicalTrials.gov Identifier: NCT02258152 |
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Recruitment Status :
Completed
First Posted : October 7, 2014
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease Dementia (PDD) | Drug: SYN120 Drug: Placebo | Phase 2 |
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 (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 |
| 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). |
- 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.
- 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.
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Study Director: | Christopher Kenney | Acorda Therapeutics |
Documents provided by Biotie Therapies Inc.:
| 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 |
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PDD Parkinson's Disease Dementia patients taking a cholinesterase inhibitor. |
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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 |