Parkinson's Disease Dementia (PDD) Clinical Trial
— SYNAPSEOfficial 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)
| Verified date | April 2019 |
| Source | Biotie Therapies Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | October 3, 2017 |
| Est. primary completion date | October 3, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Augusta University | Augusta | Georgia |
| United States | Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center | Baltimore | Maryland |
| United States | The University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Parkinson's Disease & Movement Disorder Center of Boca Raton | Boca Raton | Florida |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Northwestern University, Feinberg School of Medicine | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Duke University | Durham | North Carolina |
| United States | Struthers Parkinson's Center | Golden Valley | Minnesota |
| United States | Baylor Univeristy | Houston | Texas |
| United States | Houston Methodist Neurological Institute/Movement Disorders Clinic | Houston | Texas |
| United States | University of Iowa, Carver College of Medicine | Iowa City | Iowa |
| United States | Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center | Kansas City | Kansas |
| United States | UC San Diego | La Jolla | California |
| United States | Parkinson's Disease Movement Disorder Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Atlantic Neuroscience Institute | Summit | New Jersey |
| United States | Banner Sun Health Research Institute | Sun City | Arizona |
| United States | Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Biotie Therapies Inc. | Acorda Therapeutics, Massachusetts General Hospital, Michael J. Fox Foundation for Parkinson's Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Primary Efficacy Objective of This Study is to Assess the Efficacy of SYN120 on Cognition as Determined by the Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention in Patients With Parkinson's Disease. | To access the effect of SYN-120 for Continuity of Attention, a measure which reflects the ability to sustain attention and avoid error The Cognitive Drug Research Computerized Cognition Battery is a computerized neuropsychological test battery to assess cognitive tasks based on measures of Vigilance (1 - 180 seconds) and Choice Reaction Time (1 - 120 seconds). The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test. The ability to keep mind on a single task over time. COA is calculated as (VIGACC*0.45) + (CRTACC*0.5) - where VIGACC is digit vigilance accuracy, CRTACC is choice reaction time accuracy. Higher COA scores represent greater sustained attention and avoidance of errors. |
up to Week 16 | |
| Secondary | To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM) | To access the effects of SYN120 for Quality of Episodic Memory. QEM measures the ability to store, hold, and retrieve information of an episodic nature. The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test. Quality of Episodic Memory is calculated as (DRECOACC + DRECNACC - 100) + (DPICOACC + DPICNACC - 100) +((IRCL - IRCLERR)*100 / 15) + ((DRCL - DRCLERR)*100 / 15), where DRECOACC is Word Recognition original stimuli accuracy (1 - 120 seconds), DRECNACC is word recognition new stimuli accuracy, DPICOACC is Picture Recognition original stimuli accuracy (1 - 120.5 seconds), DPICNACC is picture recognition new stimuli accuracy, IRCL is Immediate Word Recall (1 - 120.5 seconds), IRCLERR is immediate word recall errors, DRCL is Delayed Word Recall (1 - 120.5 seconds), and DRCLERR is delayed word recall errors. Higher QEM scores greater ability to retain memory. |
up to Week 16 |