Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Parkinson Disease
Cognitive Dysfunction
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief Summary
The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's d...
Eligibility Criteria
Inclusion
- Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic PD according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet MDS Task Force Criteria for MCI in PD.
- Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
- Meet criteria for Hoehn \& Yahr Stage I to III (mild to moderate motor severity) at Screening.
- Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator.
Exclusion
- Have a diagnosis of dementia of any etiology, including but not limited to: Dementia associated with PD (probable or possible), Dementia with Lewy Bodies, Alzheimer's Dementia, and Vascular Dementia.
- Have any indication of parkinsonism other than idiopathic PD.
- In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
- Have an ongoing central nervous system condition other than idiopathic PD, including active neurologic and/or nonremitted psychiatric disorders, in the opinion of the investigator.
- Have a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury.
- Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04476017
Start Date
July 31 2020
End Date
March 25 2022
Last Update
September 15 2025
Active Locations (4)
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1
Sage Investigational Site
Long Beach, California, United States, 90806
2
Sage Investigational Site
Port Charlotte, Florida, United States, 33980
3
Sage Investigational Site
West Palm Beach, Florida, United States, 33407
4
Sage Investigational Site
Chicago, Illinois, United States, 60612