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)



Status:Completed
Conditions:Parkinsons Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:6/9/2018
Start Date:December 22, 2014
End Date:October 3, 2017

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Trial Summary
Trial Overview
Inclusion Criteria
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.

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).

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
We found this trial at
20
sites
Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Albert Hung, MD
Phone: 617-643-0654
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Natividad Stover, MD
Phone: 205-975-2894
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Duke University
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Struthers Parkinson's Center
6701 Country Club Drive
Golden Valley, Minnesota 55427
888-993-5495
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Golden Valley, MN
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Augusta University
Augusta, Georgia 30912
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Augusta, GA
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Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
Baltimore, Maryland 21201
Principal Investigator: Lisa Shulman, MD
Phone: 410-328-0157
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Baltimore, MD
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Parkinson's Disease& Movement Disorder Center of Boca Raton
Boca Raton, Florida 33486
Principal Investigator: Stuart Isaacson, MD
Phone: 561-392-1818
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Boca Raton, FL
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Vanessa Hinson, MD
Phone: 843-732-9115
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Northwestern University Feinberg School of Medicine
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Tanya Simuni, MD
Phone: 312-503-0755
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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Rush University Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Jennifer Goldman, MD, MS
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Baylor Univeristy
Houston, Texas 77030
Principal Investigator: Joohi Jimenez-Shahed, MD
Phone: 713-798-6902
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Houston, TX
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Houston Methodist Neurological Institute/Movement Disorders Clinic
Houston, Texas 77030
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Houston, TX
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University of Iowa, Carver College of Medicine
Iowa City, Iowa 52245
Principal Investigator: Ergun Uc, MD
Phone: 319-356-8744
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Iowa City, IA
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Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center
Kansas City, Kansas 66160
Principal Investigator: Rajesh Pahwa, MD
Phone: 913-588-6989
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Kansas City, KS
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UC San Diego
La Jolla, California 92093
Principal Investigator: Fatta Nahab, MD
Phone: 858-822-1399
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La Jolla, CA
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Parkinson's Disease Movement Disorder Center
Philadelphia, Pennsylvania 19107
Principal Investigator: Nabila Dahodwala, MD
Phone: 215-615-3085
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Philadelphia, PA
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Thomas Jefferson University
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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Atlantic Neuroscience Institute
Summit, New Jersey 07901
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Summit, NJ
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Banner Sun Health Research Institute
Sun City, Arizona 85351
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Sun City, AZ
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Wake Forest Baptist Health Sciences
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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