Clinical trial NCT04476017: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Official title: An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Cognitive Dysfunction
Keywords: Parkinson's Disease
Cognitive Dysfunction
SAGE-718
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study had two parts: Part A and Part B with unique participants for each study part. Part B was started after Part A was completed.
Primary purpose: TREATMENT

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 disease mild cognitive impairment (PD-MCI).


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
3. Meet criteria for Hoehn \& Yahr Stage I to III (mild to moderate motor severity) at Screening.
4. Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator.

Exclusion Criteria:

1. 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.
2. Have any indication of parkinsonism other than idiopathic PD.
3. In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
4. 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.
5. 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.
6. Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.

Primary outcomes:
measure: Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose of study drug up to 28 days
measure: Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose of study drug up to 42 days
Secondary outcomes:
measure: Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
timeFrame: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
measure: Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments
timeFrame: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
measure: Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
timeFrame: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
measure: Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Sage Investigational Site
state: California
city: Port Charlotte
country: United States
facility: Sage Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Sage Investigational Site
state: Florida
city: Chicago
country: United States
facility: Sage Investigational Site
state: Illinois
Study officials:
References: