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Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 50 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 and meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria). 2. 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. 3. Meet criteria for modified 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. 5. 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.

Exclusion Criteria

  1. Have a diagnosis of dementia of any etiology, including but not limited to: 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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants received SAGE-718-matching placebo, oral capsules, once daily (QD), in the morning for 42 days.
  • Drug: SAGE-718-matching placebo
    Oral capsules
Experimental
SAGE-718 		Participants received SAGE-718, 1.2 milligrams (mg), oral capsules, QD in the morning for 42 days.
  • Drug: SAGE-718
    Oral capsules

Recruiting Locations

More Details

NCT ID
NCT05318937
Status
Completed
Sponsor
Sage Therapeutics

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.