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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2022

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Matching placebo Capsules
  • Experimental: NYX-458 30 mg
    • Single oral dose taken daily for 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in physical examination
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Physical examination
  • Rates of adverse events and serious adverse events
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Adverse events and serious adverse events
  • Rates of early termination due to adverse events
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Early termination due to adverse events
  • Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Vital signs, clinical laboratory values, and electrocardiogram results
  • Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Neuropsychiatric Inventory (NPI-12) – NPI-12 assesses 12 behavioral domains common in dementia. Higher scores indicate more severe illness.
  • Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS)
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
  • Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 4
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 4 includes 6 items assessing motor complications, higher scores indicate more serious illness.
  • Change in total score of the Sheehan Suicidality Tracking Scale (S-STS)
    • Time Frame: Subjects will be followed up to 14 days post-dose
    • Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely

Secondary Measures

  • Change from baseline in the One Back test
    • Time Frame: Week 12
    • The One Back test is a measure of working memory
  • Change from baseline in the Two Back test
    • Time Frame: Week 12
    • The Two Back test is a measure of working memory
  • Change from baseline in the Groton Maze Learning Test
    • Time Frame: Week 12
    • The Groton Maze Learning test is a measure of problem solving and reasoning
  • Change from baseline in the Identification Test
    • Time Frame: Week 12
    • The Identification test is a measure of visual attention
  • Change from baseline in the International Shopping List Test
    • Time Frame: Week 12
    • The International Shopping List test is a measure of verbal learning
  • Change from baseline on Continuous Paired Associate Learning Test
    • Time Frame: Week 12
    • The Continuous Paired Associate Learning test is a measure of visual associate memory

Participating in This Clinical Trial

Inclusion Criteria

  • Informed Consent – Diagnosis of Parkinson's disease and mild cognitive impairment or mild dementia OR diagnosis of mild cognitive impairment or mild dementia with Lewy bodies – Presence of subjective cognitive complaints by the patient – Verifiable impairment, as defined a CGI-S (Clinical Global Impression-Severity) score of at least 3 (mildly ill). – Score on the MoCA (Montreal Cognitive Assessment) between 15 and 25, inclusive. – Stable anti-parkinsonian regimen (if applicable) – Has a study partner who can accompany the subject at specified study visits Exclusion Criteria:

  • Clinically meaningful motor complications – Current use of medications with primarily central nervous system activities – Other clinically significant medical histories that may interfere with completing the study.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aptinyx
  • Collaborator
    • CogState Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.