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) (SYNAPSE)
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|ClinicalTrials.gov Identifier: NCT02258152|
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Dementia (PDD)||Drug: SYN120 Drug: Placebo||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||December 22, 2014|
|Actual Primary Completion Date :||October 3, 2017|
|Actual Study Completion Date :||October 3, 2017|
|Placebo Comparator: Placebo||
SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
- Change in Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention from baseline [ Time Frame: Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258152
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