Adults 50 to 80, any sex, with Mild Cognitive Impairment or Mild Dementia. 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 84
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 baselin
Group
Value
95% CI
Placebo
3.8
± 0.77
SAGE-718
5.3
± 0.79
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)Secondary· Up to Day 112
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
50
SAGE-718
42
Number of Participants With at Least One TEAE by SeveritySecondary· Up to Day 112
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
29
SAGE-718
20
Moderate
Group
Value
95% CI
Placebo
19
SAGE-718
20
Severe
Group
Value
95% CI
Placebo
2
SAGE-718
2
Number of Participants Who Withdrew From Study Due to TEAEsSecondary· Up to Day 112
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
2
SAGE-718
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 112.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 5/86 (6%)
Deaths: 1/86
SAGE-718
Serious: 4/84 (5%)
Deaths: 0/84
Serious adverse events (11 terms)
Reaction
System
Placebo
SAGE-718
Prostate cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NCT05655520 — A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
· Phase 3
· terminated
NCT05318937 — A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment
· 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
Other recruiting trials for Mild Cognitive Impairment
Currently open trials in the same condition.
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· Phase 1
· recruiting
NCT07220694 — Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairmen
· NA
· recruiting
NCT06983769 — CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
· NA
· recruiting
NCT07318038 — The Use of Rhythmic Light Therapy in Mild Cognitive Impairment
· NA
· recruiting
Other Supernus Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT07226661 — Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
· Phase 2
· recruiting
NCT07141329 — SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
· Phase 2
· recruiting
NCT07219927 — Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:
· recruiting
NCT06185985 — Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms
· Phase 4
· completed
NCT06259331 — Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
· Phase 4
· completed
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: 15 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/NCT05619692.