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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02258152
Recruitment Status : Active, not recruiting
First Posted : October 7, 2014
Last Update Posted : August 3, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dementia (PDD) Drug: SYN120 Drug: Placebo Phase 2

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo QD
Experimental: SYN120 Drug: SYN120
SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).


Outcome Measures

Primary Outcome Measures :
  1. Change in Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention from baseline [ Time Frame: Week 16 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


  Show 20 Study Locations
Sponsors and Collaborators
Biotie Therapies Inc.
Michael J. Fox Foundation for Parkinson's Research
Parkinson's Study Group
Massachusetts General Hospital
Acorda Therapeutics
More Information

Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT02258152     History of Changes
Other Study ID Numbers: SYN120-CL03
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by Biotie Therapies Inc.:
PDD
Parkinson's Disease Dementia
patients taking a cholinesterase inhibitor.

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs