SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) (SYNAPSE)
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)
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- The University of Alabama at Birmingham
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Arizona
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Sun City、Arizona、美国、85351
- Banner Sun Health Research Institute
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California
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La Jolla、California、美国、92037
- UC San Diego
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Florida
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Boca Raton、Florida、美国、33486
- Parkinson's Disease & Movement Disorder Center of Boca Raton
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Georgia
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Augusta、Georgia、美国、29847
- Augusta University
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Medical Center
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Chicago、Illinois、美国、60611
- Northwestern University, Feinberg School of Medicine
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Iowa
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Iowa City、Iowa、美国、52245
- University of Iowa, Carver College of Medicine
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Kansas
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Kansas City、Kansas、美国、66016
- Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
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Maryland
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Baltimore、Maryland、美国、21201
- Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Minnesota
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Golden Valley、Minnesota、美国、55427
- Struthers Parkinson's Center
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New Jersey
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Summit、New Jersey、美国、07901
- Atlantic Neuroscience Institute
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North Carolina
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Durham、North Carolina、美国、27705
- Duke University
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist Health Sciences
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
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Philadelphia、Pennsylvania、美国、19107
- Parkinson's Disease Movement Disorder Center
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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Texas
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Houston、Texas、美国、77030
- Baylor Univeristy
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Houston、Texas、美国、77030
- Houston Methodist Neurological Institute/Movement Disorders Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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安慰剂 QD
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实验性的：SYN120
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SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
大体时间：up to Week 16
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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. |
up to Week 16
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
大体时间：up to Week 16
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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. |
up to Week 16
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合作者和调查者
合作者
调查人员
- 研究主任：Christopher Kenney、Acorda Therapeutics
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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