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NYX-458 for Lewy Body Dementia

Phase 2
Waitlist Available
Research Sponsored by Aptinyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be followed up to 14 days post-dose

Summary

This trial will test the effects of NYX-458 on mild cognitive impairment, mild dementia, and prodromal or manifest Lewy body dementia.

Eligible Conditions
  • Lewy Body Dementia
  • Forgetfulness
  • Overactive Bladder
  • Lewy Body Disease
  • Parkinson's Disease
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be followed up to 14 days post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be followed up to 14 days post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)
Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4
Change from baseline in physical examination
+5 more
Secondary study objectives
Change from baseline in the Groton Maze Learning Test
Change from baseline in the Identification Test
Change from baseline in the International Shopping List Test
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NYX-458 30 mgExperimental Treatment1 Intervention
Single oral dose taken daily for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo Capsules

Find a Location

Who is running the clinical trial?

CogState Ltd.Industry Sponsor
7 Previous Clinical Trials
314 Total Patients Enrolled
AptinyxLead Sponsor
8 Previous Clinical Trials
1,235 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
64 Previous Clinical Trials
14,690 Total Patients Enrolled
~16 spots leftby Nov 2025
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