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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- The University of Alabama at Birmingham
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Arizona
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Sun City, Arizona, Stati Uniti, 85351
- Banner Sun Health Research Institute
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California
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La Jolla, California, Stati Uniti, 92037
- UC San Diego
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Florida
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Boca Raton, Florida, Stati Uniti, 33486
- Parkinson's Disease & Movement Disorder Center of Boca Raton
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Georgia
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Augusta, Georgia, Stati Uniti, 29847
- Augusta University
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University, Feinberg School of Medicine
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Iowa
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Iowa City, Iowa, Stati Uniti, 52245
- University of Iowa, Carver College of Medicine
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Kansas
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Kansas City, Kansas, Stati Uniti, 66016
- Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Minnesota
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Golden Valley, Minnesota, Stati Uniti, 55427
- Struthers Parkinson's Center
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New Jersey
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Summit, New Jersey, Stati Uniti, 07901
- Atlantic Neuroscience Institute
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Duke University
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest Baptist Health Sciences
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Parkinson's Disease Movement Disorder Center
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, Stati Uniti, 77030
- Baylor Univeristy
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Houston, Texas, Stati Uniti, 77030
- Houston Methodist Neurological Institute/Movement Disorders Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
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QD placebo
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Christopher Kenney, Acorda Therapeutics
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SYN120-CL03
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