SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

NCT02258152 | Completed Phase 2 Results DMC

• 1 other identifier: SYN120-CL03
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 20

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.

Conditions

Parkinson's Disease Dementia (PDD)

Keywords

PDD; Parkinson's Disease Dementia; patients taking a cholinesterase inhibitor.

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (1)

• To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)

  up to Week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

SYN120

EXPERIMENTAL

Drug: SYN120

Interventions

SYN120 DRUG

SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).

SYN120

Placebo DRUG

Placebo QD

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's Disease Dementia
• Patient has a routine caregiver
• Taking a stable cholinesterase inhibitor.
• Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotie Therapies Inc.: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Massachusetts General Hospital: collaborator
• Acorda Therapeutics: collaborator

Study Sites (20)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

UC San Diego

La Jolla, California, 92037, United States

Location

Parkinson's Disease & Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Augusta University

Augusta, Georgia, 29847, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Iowa, Carver College of Medicine

Iowa City, Iowa, 52245, United States

Location

Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center

Kansas City, Kansas, 66016, United States

Location

Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

Atlantic Neuroscience Institute

Summit, New Jersey, 07901, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Parkinson's Disease Movement Disorder Center

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor Univeristy

Houston, Texas, 77030, United States

Location

Houston Methodist Neurological Institute/Movement Disorders Clinic

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Fernandez HH, Weintraub D, Macklin E, Litvan I, Schwarzschild MA, Eberling J, Videnovic A, Kenney CJ; Parkinson Study Group SYNAPSE Investigators. Safety, tolerability, and preliminary efficacy of SYN120, a dual 5-HT6/5-HT2A antagonist, for the treatment of Parkinson disease dementia: A randomized, controlled, proof-of-concept trial. Parkinsonism Relat Disord. 2023 Sep;114:105511. doi: 10.1016/j.parkreldis.2023.105511. Epub 2023 Jul 13.

  PMID: 37532622 DERIVED

Results Point of Contact

• Title: Christopher Kenney, Senior Vice President - Medical Affairs
• Organization: Acorda Therapeutics

ckenney@acorda.com

914-326-5775

Study Officials

• Christopher Kenney

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 7, 2014
• Study Start: December 22, 2014
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-04

Locations

US (20)