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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02258152 |
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Date of registration:
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03/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
SYNAPSE |
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Scientific title:
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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) |
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Date of first enrolment:
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December 22, 2014 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02258152 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher Kenney |
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Address:
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Telephone:
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Email:
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Affiliation:
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Acorda Therapeutics |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease Dementia (PDD)
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Intervention(s)
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Drug: Placebo
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Drug: SYN120
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Primary Outcome(s)
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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.
[Time Frame: up to Week 16]
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Secondary Outcome(s)
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To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
[Time Frame: up to Week 16]
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Secondary ID(s)
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SYN120-CL03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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