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Could SAGE-718 boost brain power in Parkinson's?

NCT ID NCT05318937

Symptom relief Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a drug called SAGE-718 in 86 people with Parkinson's disease who have mild memory or thinking problems. Participants took either the drug or a placebo pill for a set time. The main goal was to see if SAGE-718 could improve processing speed, measured by a symbol-matching test. The trial is now complete, and results will show if the drug is safe and helps with cognitive symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAGE-718
What this could lead to
If it works, this could point toward a treatment for cognitive decline in Parkinson's disease, helping with memory and thinking speed.
What could go wrong
This is an early phase 2 trial with only 86 people, so results may not apply to everyone. The drug may not improve cognition or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

86 people

The number who actually took part.

Started

Jun 2022

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

cognitive disorder Cognitive Dysfunction Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive dysfunction Parkinson disease

Contacts and locations

Locations

  • Sage Investigational Site

    Sun City, Arizona, 85351, United States

  • Sage Investigational Site

    Little Rock, Arkansas, 72205, United States

  • Sage Investigational Site

    Fresno, California, 93710, United States

  • Sage Investigational Site

    Long Beach, California, 90806, United States

  • Sage Investigational Site

    Los Angeles, California, 90048, United States

  • Sage Investigational Site

    Reseda, California, 91335, United States

  • Sage Investigational Site

    Sacramento, California, 95816, United States

  • Sage Investigational Site

    Englewood, Colorado, 80113, United States

  • Sage Investigational Site

    Vernon, Connecticut, 06066, United States

  • Sage Investigational Site

    Boca Raton, Florida, 33431, United States

  • Sage Investigational Site

    Boca Raton, Florida, 33486, United States

  • Sage Investigational Site

    Hialeah, Florida, 33012, United States

  • Sage Investigational Site

    Miami, Florida, 33032, United States

  • Sage Investigational Site

    Orlando, Florida, 32789, United States

  • Sage Investigational Site

    Port Orange, Florida, 32127, United States

  • Sage Investigational Site

    Tampa, Florida, 33609, United States

  • Sage Investigational Site

    Tampa, Florida, 33613, United States

  • Sage Investigational Site

    Decatur, Georgia, 30030, United States

  • Sage Investigational Site

    Chicago, Illinois, 60611, United States

  • Sage Investigational Site

    Kansas City, Kansas, 66160, United States

  • Sage Investigational Site

    Bloomington, Minnesota, 55425, United States

  • Sage Investigational Site

    Las Vegas, Nevada, 89106, United States

  • Sage Investigational Site

    Albany, New York, 12208, United States

  • Sage Investigational Site

    New York, New York, 10019, United States

  • Sage Investigational Site

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

  • Sage Investigational Site

    Williamsville, New York, 14221, United States

  • Sage Investigational Site

    Woodmere, New York, 11598, United States

  • Sage Investigational Site

    Raleigh, North Carolina, 27607, United States

  • Sage Investigational Site

    Cincinnati, Ohio, 45221, United States

  • Sage Investigational Site

    Columbus, Ohio, 43221, United States

  • Sage Investigational Site

    Toledo, Ohio, 43614, United States

  • Sage Investigational Site

    Memphis, Tennessee, 38157, United States

  • Sage Investigational Site

    Nashville, Tennessee, 37232, United States

  • Sage Investigational Site

    Houston, Texas, 77030, United States

  • Sage Investigational Site

    San Antonio, Texas, 78229, United States

  • Sage Investigational Site

    Burlington, Vermont, 05401, United States

  • Sage Investigational Site

    Virginia Beach, Virginia, 23502, United States

  • Sage Investigational Site

    Madison, Wisconsin, 53792, United States

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