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Could a new pill help Parkinson's patients think more clearly?

NCT ID NCT04476017

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This small study tested an experimental drug called SAGE-718 in 18 people with Parkinson's disease who also had mild thinking and memory problems. The main goal was to see if the drug was safe and tolerable. Researchers also looked at whether it might help with thinking, mood, and movement 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 (oral tablets)
What this could lead to
If successful, this could point toward a treatment to ease thinking and memory problems in people with Parkinson's disease.
What could go wrong
This was a very small, early-phase study with only 18 participants, so results may not apply broadly. The drug's effectiveness is still uncertain.

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

18 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2022

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 PD according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet MDS Task Force Criteria for MCI in PD. 2. Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening. 3. Meet criteria for 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. 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 indication of parkinsonism other than idiopathic PD. 3. In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD. 4. Have an ongoing central nervous system condition other than idiopathic PD, including active neurologic and/or nonremitted psychiatric disorders, in the opinion of the investigator. 5. Have a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury. 6. Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.

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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

    Long Beach, California, 90806, United States

  • Sage Investigational Site

    Port Charlotte, Florida, 33980, United States

  • Sage Investigational Site

    West Palm Beach, Florida, 33407, United States

  • Sage Investigational Site

    Chicago, Illinois, 60612, United States

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