Clinical trial NCT02258152: SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease Dementia (PDD)
Keywords: PDD
Parkinson's Disease Dementia
patients taking a cholinesterase inhibitor.
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Massachusetts General Hospital
name: Acorda Therapeutics
First posted: 2014-10-07
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to Week 16
Secondary outcomes:
measure: To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
timeFrame: up to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease & Movement Disorder Center of Boca Raton
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa, Carver College of Medicine
state: Iowa
city: Kansas City
country: United States
facility: Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Summit
country: United States
facility: Atlantic Neuroscience Institute
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Parkinson's Disease Movement Disorder Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Baylor Univeristy
state: Texas
city: Houston
country: United States
facility: Houston Methodist Neurological Institute/Movement Disorders Clinic
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: Christopher Kenney
role: STUDY_DIRECTOR
References: