A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

Criteria

Inclusion Criteria:

1. 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; Meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria).

2. For participants meeting Level 1 PD-MCI criteria, have a Montreal Cognitive Assessment (MoCA) score of 20 to 25 (inclusive) at Screening.

3. For participants meeting Level 2 PD-MCI criteria (within the past year), have a MoCA score of 18 to 25 (inclusive) at Screening.

4. Meet criteria for modified Hoehn & Yahr Stage I to III (mild to moderate motor severity) at Screening.

5. 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 parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism.

3. In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures.

4. Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.

5. Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.

6. Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury.

7. Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).