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 |
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.
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).
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
Boca Raton, Florida 33486
Principal Investigator: Stuart Isaacson, MD
Phone: 561-392-1818
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
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...
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Albert Hung, MD
Phone: 617-643-0654
Click here to add this to my saved trials
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Baltimore, Maryland 21201
Principal Investigator: Lisa Shulman, MD
Phone: 410-328-0157
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
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...
Click here to add this to my saved trials
303 E Chicago Ave
Chicago, Illinois 60611
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,...
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
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...
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Joohi Jimenez-Shahed, MD
Phone: 713-798-6902
Click here to add this to my saved trials
Click here to add this to my saved trials
Iowa City, Iowa 52245
Principal Investigator: Ergun Uc, MD
Phone: 319-356-8744
Click here to add this to my saved trials
Kansas City, Kansas 66160
Principal Investigator: Rajesh Pahwa, MD
Phone: 913-588-6989
Click here to add this to my saved trials
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
Principal Investigator: Nabila Dahodwala, MD
Phone: 215-615-3085
Click here to add this to my saved trials
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials