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Parkinson DiseasePhase 2NCT05318937

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

A Phase 2 study testing SAGE-718 in people with Parkinson Disease and Cognitive Dysfunction, run by Supernus Pharmaceuticals, Inc. at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson Disease, Cognitive Dysfunction
What is being tested?
SAGE-718
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
38 sitesUnited States
Study dates
6 Jun 2022to 23 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Sage Investigational Site

    Albany, New York, 12208

  • Sage Investigational Site

    Bloomington, Minnesota, 55425

  • Sage Investigational Site

    Boca Raton, Florida, 33431

  • Sage Investigational Site

    Boca Raton, Florida, 33486

  • Sage Investigational Site

    Burlington, Vermont, 05401

  • Sage Investigational Site

    Chicago, Illinois, 60611

  • Sage Investigational Site

    Cincinnati, Ohio, 45221

  • Sage Investigational Site

    Columbus, Ohio, 43221

  • Sage Investigational Site

    Decatur, Georgia, 30030

  • Sage Investigational Site

    Englewood, Colorado, 80113

  • Sage Investigational Site

    Fresno, California, 93710

  • Sage Investigational Site

    Hialeah, Florida, 33012

  • Sage Investigational Site

    Houston, Texas, 77030

  • Sage Investigational Site

    Kansas City, Kansas, 66160

  • Sage Investigational Site

    Las Vegas, Nevada, 89106

  • Sage Investigational Site

    Little Rock, Arkansas, 72205

  • Sage Investigational Site

    Long Beach, California, 90806

  • Sage Investigational Site

    Los Angeles, California, 90048

  • Sage Investigational Site

    Madison, Wisconsin, 53792

  • Sage Investigational Site

    Memphis, Tennessee, 38157

  • Sage Investigational Site

    Miami, Florida, 33032

  • Sage Investigational Site

    Nashville, Tennessee, 37232

  • Sage Investigational Site

    New York, New York, 10019

  • Sage Investigational Site

    Orlando, Florida, 32789

  • Sage Investigational Site

    Port Orange, Florida, 32127

  • Sage Investigational Site

    Raleigh, North Carolina, 27607

  • Sage Investigational Site

    Reseda, California, 91335

  • Sage Investigational Site

    Sacramento, California, 95816

  • Sage Investigational Site

    San Antonio, Texas, 78229

  • Sage Investigational Site

    Stony Brook, New York, 11794-8121

  • Sage Investigational Site

    Sun City, Arizona, 85351

  • Sage Investigational Site

    Tampa, Florida, 33609

  • Sage Investigational Site

    Tampa, Florida, 33613

  • Sage Investigational Site

    Toledo, Ohio, 43614

  • Sage Investigational Site

    Vernon, Connecticut, 06066

  • Sage Investigational Site

    Virginia Beach, Virginia, 23502

  • Sage Investigational Site

    Williamsville, New York, 14221

  • Sage Investigational Site

    Woodmere, New York, 11598

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment

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).

Being tested
SAGE-718-matching placebo, SAGE-718
Medical subject headings
Parkinson Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAGE-718-matching placeboDrug

    Oral capsules

  • SAGE-718Drug

    Oral capsules

Study groups in NCT05318937
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received SAGE-718-matching placebo, oral capsules, once daily (QD), in the morning for 42 days.
Receives: Drug: SAGE-718-matching placebo
SAGE-718ExperimentalParticipants received SAGE-718, 1.2 milligrams (mg), oral capsules, QD in the morning for 42 days.
Receives: Drug: SAGE-718

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Day 42

Secondary outcomes (3)

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

    An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

    Measured: Up to Day 70

  2. Number of Participants With at Least One TEAE by Severity

    A TEAE is defined as any AE on or after the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as:

    • Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms
    • Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed
    • Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized.

    Participant with multiple instances of events is counted only once using maximum intensity.

    Measured: Up to Day 70

  3. Number of Participants Who Withdrew From Study Due to TEAEs

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

    Measured: Up to Day 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start6 Jun 2022
  3. Primary completion17 Jan 2024
  4. Study completion23 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318937
Sponsor's protocol ID
718-CNP-202
Status last verified
Sep 2025
First submitted
1 Apr 2022
Last updated
12 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAGE-718 in people with Parkinson Disease and Cognitive Dysfunction, run by Supernus Pharmaceuticals, Inc. at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score (time frame: Baseline, Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05318937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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