Adults 50 to 75, any sex, with Parkinson Disease or Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test ScorePrimary· Baseline, Day 42
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
Group
Value
95% CI
Placebo
2.0
± 1.44
SAGE-718
2.0
± 1.48
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)Secondary· Up to Day 70
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
Group
Value
95% CI
Placebo
27
SAGE-718
21
Number of Participants With at Least One TEAE by SeveritySecondary· Up to Day 70
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 ma
Mild
Group
Value
95% CI
Placebo
15
SAGE-718
14
Moderate
Group
Value
95% CI
Placebo
10
SAGE-718
5
Severe
Group
Value
95% CI
Placebo
2
SAGE-718
2
Number of Participants Who Withdrew From Study Due to TEAEsSecondary· Up to Day 70
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 conditi
Group
Value
95% CI
Placebo
0
SAGE-718
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 70.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 2/43 (5%)
Deaths: 1/43
SAGE-718
Serious: 3/43 (7%)
Deaths: 0/43
Serious adverse events (8 terms)
Reaction
System
Placebo
SAGE-718
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05655520 — A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
· Phase 3
· terminated
NCT05619692 — A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzhe
· Phase 2
· completed
NCT05358821 — 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease
· Phase 2
· completed
NCT05107128 — A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
· Phase 2
· completed
NCT04602624 — A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Demen
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc.
Last refreshed: 12 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05318937.