What is the Purpose of this Study?
The purpose of this study is to evaluate the effect of an investigational drug called SAGE-718 on cognitive performance in people with Parkinson’s disease - mild cognitive impairment (PD-MCI). Mild cognitive impairment is a condition that is associated with decreased quality of life and impaired functioning; it is common in people who have Parkinson’s disease. People with PD-MCI are at a high risk for developing dementia. The study will evaluate the safety and tolerability SAGE-718, as well as its effect on health-related quality of life, daily functioning, and neuropsychiatric symptoms. Researchers also aim to learn how the body absorbs, breaks down, and removes SAGE-718 from the body and how it works inside the body. Study procedures include interviews, laboratory tests, administration of study drug, dosing diary tracking, electrocardiograms, and questionnaires.
Eligibility
- 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 MoCA: For participants meeting Level 1 PD-MCI criteria, have a Montreal Cognitive Assessment (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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment