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

NCT ID: NCT05318937

Last Updated: 2025-09-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2024-02-23

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants received SAGE-718-matching placebo, oral capsules, once daily (QD), in the morning for 42 days.

Group Type PLACEBO_COMPARATOR

SAGE-718-matching placebo

Intervention Type DRUG

Oral capsules

SAGE-718

Participants received SAGE-718, 1.2 milligrams (mg), oral capsules, QD in the morning for 42 days.

Group Type EXPERIMENTAL

SAGE-718

Intervention Type DRUG

Oral capsules

Interventions

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SAGE-718-matching placebo

Oral capsules

Intervention Type DRUG

SAGE-718

Oral capsules

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Sun City, Arizona, United States

Site Status

Sage Investigational Site

Little Rock, Arkansas, United States

Site Status

Sage Investigational Site

Fresno, California, United States

Site Status

Sage Investigational Site

Long Beach, California, United States

Site Status

Sage Investigational Site

Los Angeles, California, United States

Site Status

Sage Investigational Site

Reseda, California, United States

Site Status

Sage Investigational Site

Sacramento, California, United States

Site Status

Sage Investigational Site

Englewood, Colorado, United States

Site Status

Sage Investigational Site

Vernon, Connecticut, United States

Site Status

Sage Investigational Site

Boca Raton, Florida, United States

Site Status

Sage Investigational Site

Boca Raton, Florida, United States

Site Status

Sage Investigational Site

Hialeah, Florida, United States

Site Status

Sage Investigational Site

Miami, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Port Orange, Florida, United States

Site Status

Sage Investigational Site

Tampa, Florida, United States

Site Status

Sage Investigational Site

Tampa, Florida, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Kansas City, Kansas, United States

Site Status

Sage Investigational Site

Bloomington, Minnesota, United States

Site Status

Sage Investigational Site

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Albany, New York, United States

Site Status

Sage Investigational Site

New York, New York, United States

Site Status

Sage Investigational Site

Stony Brook, New York, United States

Site Status

Sage Investigational Site

Williamsville, New York, United States

Site Status

Sage Investigational Site

Woodmere, New York, United States

Site Status

Sage Investigational Site

Raleigh, North Carolina, United States

Site Status

Sage Investigational Site

Cincinnati, Ohio, United States

Site Status

Sage Investigational Site

Columbus, Ohio, United States

Site Status

Sage Investigational Site

Toledo, Ohio, United States

Site Status

Sage Investigational Site

Memphis, Tennessee, United States

Site Status

Sage Investigational Site

Nashville, Tennessee, United States

Site Status

Sage Investigational Site

Houston, Texas, United States

Site Status

Sage Investigational Site

San Antonio, Texas, United States

Site Status

Sage Investigational Site

Burlington, Vermont, United States

Site Status

Sage Investigational Site

Virginia Beach, Virginia, United States

Site Status

Sage Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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718-CNP-202

Identifier Type: -

Identifier Source: org_study_id

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