NCT04602624

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

An Open-Label Evaluation of the Safety and Tolerability 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: 26 (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 safety and tolerability of SAGE-718 and its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).

Conditions

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Dementia

Interventions

Type	Name	Description
DRUG	SAGE-718	SAGE-718 oral tablets.

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2020-10-26
• Last updated: 2025-09-15
• Results posted: 2024-10-10

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study