Phase 2
Completed N=11
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Source: ClinicalTrials.gov NCT04476017 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 45.5 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) |
45.5 | — |
| PRIMARY Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) |
14.3 | — |
| SECONDARY Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements |
0; 0 | — |
| SECONDARY Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments |
0; 0 | — |
| SECONDARY Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements |
0; 0 | — |
| SECONDARY 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) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04476017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.