NCT05619692

A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Alzheimer's Disease.

Conditions

• Mild Cognitive Impairment
• Mild Dementia
• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	SAGE-718	Softgel lipid capsules.
DRUG	SAGE-718-matching Placebo	Softgel lipid capsules.

Timeline

• Start date: 2022-11-29
• Primary completion: 2024-06-05
• Completion: 2024-07-09
• First posted: 2022-11-17
• Last updated: 2025-09-15
• Results posted: 2025-06-18

Locations

39 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study