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)
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258152
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