A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
NCT05619692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2025-09-15
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
- DRUG
-
SAGE-718
Softgel lipid capsules.
- DRUG
-
SAGE-718-matching Placebo
Softgel lipid capsules.
Sponsors & Collaborators
-
Supernus Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-29
- Primary Completion
- 2024-06-05
- Completion
- 2024-07-09
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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