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

NCT05318937 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 718-CNP-202
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 38

Brief 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).

Conditions

Parkinson Disease; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score

  The WAIS-IV coding test is a valid and sensitive measure of cognitive dysfunction that correlates with real-world functional outcomes (e.g., the ability to accomplish everyday tasks) and recovery from functional disability used to assess processing speed. The participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The total score ranges from 0 to 135 and is based on the total number of codes correctly completed over a 120-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed. Least Squares (LS) Means were calculated using a mixed-effects model for repeated measures (MMRM) approach.

  Baseline, Day 42

Secondary Outcomes (3)

• Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

  Up to Day 70

• Number of Participants With at Least One TEAE by Severity

  Up to Day 70

• Number of Participants Who Withdrew From Study Due to TEAEs

  Up to Day 70

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: SAGE-718-matching placebo

SAGE-718

EXPERIMENTAL

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

Drug: SAGE-718

Interventions

SAGE-718-matching placebo DRUG

Oral capsules

Placebo

SAGE-718 DRUG

Oral capsules

SAGE-718

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have a diagnosis of dementia of any etiology, including but not limited to: Dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia.
• 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 an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.
• Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.
• 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).

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (38)

Sage Investigational Site

Sun City, Arizona, 85351, United States

Location

Sage Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Sage Investigational Site

Fresno, California, 93710, United States

Location

Sage Investigational Site

Long Beach, California, 90806, United States

Location

Sage Investigational Site

Los Angeles, California, 90048, United States

Location

Sage Investigational Site

Reseda, California, 91335, United States

Location

Sage Investigational Site

Sacramento, California, 95816, United States

Location

Sage Investigational Site

Englewood, Colorado, 80113, United States

Location

Sage Investigational Site

Vernon, Connecticut, 06066, United States

Location

Sage Investigational Site

Boca Raton, Florida, 33431, United States

Location

Sage Investigational Site

Boca Raton, Florida, 33486, United States

Location

Sage Investigational Site

Hialeah, Florida, 33012, United States

Location

Sage Investigational Site

Miami, Florida, 33032, United States

Location

Sage Investigational Site

Orlando, Florida, 32789, United States

Location

Sage Investigational Site

Port Orange, Florida, 32127, United States

Location

Sage Investigational Site

Tampa, Florida, 33609, United States

Location

Sage Investigational Site

Tampa, Florida, 33613, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Chicago, Illinois, 60611, United States

Location

Sage Investigational Site

Kansas City, Kansas, 66160, United States

Location

Sage Investigational Site

Bloomington, Minnesota, 55425, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89106, United States

Location

Sage Investigational Site

Albany, New York, 12208, United States

Location

Sage Investigational Site

New York, New York, 10019, United States

Location

Sage Investigational Site

Stony Brook, New York, 11794-8121, United States

Location

Sage Investigational Site

Williamsville, New York, 14221, United States

Location

Sage Investigational Site

Woodmere, New York, 11598, United States

Location

Sage Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45221, United States

Location

Sage Investigational Site

Columbus, Ohio, 43221, United States

Location

Sage Investigational Site

Toledo, Ohio, 43614, United States

Location

Sage Investigational Site

Memphis, Tennessee, 38157, United States

Location

Sage Investigational Site

Nashville, Tennessee, 37232, United States

Location

Sage Investigational Site

Houston, Texas, 77030, United States

Location

Sage Investigational Site

San Antonio, Texas, 78229, United States

Location

Sage Investigational Site

Burlington, Vermont, 05401, United States

Location

Sage Investigational Site

Virginia Beach, Virginia, 23502, United States

Location

Sage Investigational Site

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Amy Bullock
• Organization: Sage Therapeutics

amy.bullock@sagerx.com

617-949-5151

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: June 6, 2022
• Primary Completion: January 17, 2024
• Study Completion: February 23, 2024
• Last Updated: September 12, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)