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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Alabama
-
Birmingham, Alabama, Forente stater, 35294
- The University of Alabama at Birmingham
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Arizona
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Sun City, Arizona, Forente stater, 85351
- Banner Sun Health Research Institute
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California
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La Jolla, California, Forente stater, 92037
- UC San Diego
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Florida
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Boca Raton, Florida, Forente stater, 33486
- Parkinson's Disease & Movement Disorder Center of Boca Raton
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Georgia
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Augusta, Georgia, Forente stater, 29847
- Augusta University
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forente stater, 60611
- Northwestern University, Feinberg School of Medicine
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Iowa
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Iowa City, Iowa, Forente stater, 52245
- University of Iowa, Carver College of Medicine
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Kansas
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Kansas City, Kansas, Forente stater, 66016
- Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Minnesota
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Golden Valley, Minnesota, Forente stater, 55427
- Struthers Parkinson's Center
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New Jersey
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Summit, New Jersey, Forente stater, 07901
- Atlantic Neuroscience Institute
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest Baptist Health Sciences
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Forente stater, 19107
- Parkinson's Disease Movement Disorder Center
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, Forente stater, 77030
- Baylor Univeristy
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Houston, Texas, Forente stater, 77030
- Houston Methodist Neurological Institute/Movement Disorders Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
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Placebo QD
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Eksperimentell: 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
Tidsramme: 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. |
up to Week 16
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Christopher Kenney, Acorda Therapeutics
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SYN120-CL03
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