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)

Description

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.

Study Start Date

December 2014

Estimated Completion Date

December 2016

Interventions

  • Drug: SYN120
  • Drug: Placebo

Specialties

  • Neurology: Movement Disorders
  • Physician Assistant: Neurology

MeSH Terms

  • Dementia
  • Parkinson Disease
  • SYN120

Study ID

Biotie Therapies Inc. -- SYN120-CL03

Status

Unknown

Trial ID

NCT02258152

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

80

Sponsor

Biotie Therapies Inc.

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (12)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Grace Bwala 617-643-0654 gbwala@partners.org
Parkinsons Disease Movement Disorder Center - Philadelphia, Pennsylvania 269.5 miles Eugenia Mamikonyan 215-615-3085 eugenia.mamikonyan@uphs.upenn.edu
Department of Neurology University of Maryland Parkinsons Disease Movement Disorder Center - Baltimore, Maryland 358.9 miles Michelle Cines RNMDCRCC 410-328-0157 mcines@som.umaryland.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Shonna Jenkins 843-732-9115 jenkisho@musc.edu
Northwestern University Feinberg School of Medicine - Chicago, Illinois 847.9 miles Karen Williams 312-503-0755 k-williams8@northwestern.edu
Rush University Medical Center - Chicago, Illinois 851.3 miles Lucia Blasucci RN 312-563-2900 movement_disorder@rush.edu
University of Iowa Carver College of Medicine - Iowa City, Iowa 1,048.9 miles Jeri Sieren 319-356-8744 jeri-sieren@uiowa.edu
The University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles Ashlee Rawlins RN 205-975-2894 arawlins@uab.edu
Parkinsons Disease Movement Disorder Center of Boca Raton - Boca Raton, Florida 1,221.8 miles Fannie Levinson 561-392-1818 flevinson@parkinsonscenter.org
Parkinsons Disease Movement Disorder Center University of Kansas Medical Center - Kansas City, Kansas 1,277.1 miles April Langhammer BACCRP 913-588-6989 alanghammer@kumc.edu
Baylor Univeristy - Houston, Texas 1,609.9 miles Farah Ismail 713-798-6902 farah.ismail@bcm.edu
UC San Diego - La Jolla, California 2,583.7 miles Lisette Moreno 858-822-1399 l3moreno@ucsd.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.