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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- The University of Alabama at Birmingham
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Arizona
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Sun City, Arizona, Förenta staterna, 85351
- Banner Sun Health Research Institute
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California
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La Jolla, California, Förenta staterna, 92037
- UC San Diego
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Florida
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Boca Raton, Florida, Förenta staterna, 33486
- Parkinson's Disease & Movement Disorder Center of Boca Raton
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Georgia
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Augusta, Georgia, Förenta staterna, 29847
- Augusta University
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University, Feinberg School of Medicine
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Iowa
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Iowa City, Iowa, Förenta staterna, 52245
- University of Iowa, Carver College of Medicine
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Kansas
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Kansas City, Kansas, Förenta staterna, 66016
- Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Minnesota
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Golden Valley, Minnesota, Förenta staterna, 55427
- Struthers Parkinson's Center
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New Jersey
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Summit, New Jersey, Förenta staterna, 07901
- Atlantic Neuroscience Institute
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North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Duke University
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest Baptist Health Sciences
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Parkinson's Disease Movement Disorder Center
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, Förenta staterna, 77030
- Baylor Univeristy
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Houston, Texas, Förenta staterna, 77030
- Houston Methodist Neurological Institute/Movement Disorders Clinic
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
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Placebo QD
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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.
Tidsram: 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. |
up to Week 16
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Christopher Kenney, Acorda Therapeutics
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SYN120-CL03
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