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)
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- The University of Alabama at Birmingham
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Arizona
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Sun City、Arizona、アメリカ、85351
- Banner Sun Health Research Institute
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California
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La Jolla、California、アメリカ、92037
- UC San Diego
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Florida
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Boca Raton、Florida、アメリカ、33486
- Parkinson's Disease & Movement Disorder Center of Boca Raton
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Georgia
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Augusta、Georgia、アメリカ、29847
- Augusta University
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Illinois
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Chicago、Illinois、アメリカ、60612
- Rush University Medical Center
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Chicago、Illinois、アメリカ、60611
- Northwestern University, Feinberg School of Medicine
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Iowa
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Iowa City、Iowa、アメリカ、52245
- University of Iowa, Carver College of Medicine
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Kansas
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Kansas City、Kansas、アメリカ、66016
- Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Minnesota
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Golden Valley、Minnesota、アメリカ、55427
- Struthers Parkinson's Center
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New Jersey
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Summit、New Jersey、アメリカ、07901
- Atlantic Neuroscience Institute
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke University
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest Baptist Health Sciences
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University
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Philadelphia、Pennsylvania、アメリカ、19107
- Parkinson's Disease Movement Disorder Center
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
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Texas
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Houston、Texas、アメリカ、77030
- Baylor Univeristy
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Houston、Texas、アメリカ、77030
- Houston Methodist Neurological Institute/Movement Disorders Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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プラセボ QD
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
時間枠：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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協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Christopher Kenney、Acorda Therapeutics
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
プラセボの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Consano Bio募集坐骨神経痛 | 坐骨神経根症 | 腰仙神経根症 | 腰仙神経根症候群 | 腰仙部神経根痛 | 坐骨神経痛オーストラリア
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Palacky University完了
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