NCT04148391

NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)

A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Aptinyx · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia

Detailed description

The study will be a 16 to 18-week study, including a 2 to 4-week screening period, followed by a 12-week double-blind, randomized, placebo-controlled treatment Period, and a 2-week follow-up period. Subjects eligible for the study will be randomized to receive either NYX-458 or placebo.

Conditions

• Mild Cognitive Impairment
• Mild Dementia
• Parkinson Disease
• Lewy Body Disease

Interventions

Type	Name	Description
DRUG	Placebo Oral Capsule	Matching placebo capsules.
DRUG	NYX-458	NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Timeline

• Start date: 2019-11-14
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-11-01
• Last updated: 2022-10-27

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study