NCT05318937CompletedPhase 2
A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Parkinson's disease mild cognitive impairment (PD-MCI).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 1 Apr 2022
- Start date
- 6 Jun 2022
- Primary completion date
- 17 Jan 2024
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Diseases
- Parkinson disease
- NCT number
- NCT05318937
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 86
- From 6 Jun 2022 to the primary completion date, 17 Jan 2024
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a diagnosis of dementia of any etiology, including but not limited to: Dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia.
- Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.
- Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury.
- Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).
Other
- Have any parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism.
- In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures.
- Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.
Who the study is looking for
- Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic Parkinson's disease (PD) according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria and meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria).
- Meet the following criteria for Montreal Cognitive Assessment (MoCA): For participants meeting Level 1 PD-MCI criteria, have a MoCA score of 20 to 25 (inclusive) at Screening; For participants meeting Level 2 PD-MCI criteria (within the past year), have a MoCA score of 18 to 25 (inclusive) at Screening.
- Meet criteria for modified 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.
- Must be able to complete the Color Trails Test 1 (including the ability to follow rater redirection and correct errors), and, based on participant's performance and investigator's opinion, participant is expected to be capable of engaging in prolonged cognitive testing for the duration of the study.
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.