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Active, Not Recruiting

NCT Number: 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mild Cognitive Impairment Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Lewy Body Disease Mental Disorders Mild Dementia Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aptinyx Clinical Site, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo oral capsule

Drug

Matching placebo capsules.

NYX-458

Drug

NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Primary outcomes

  1. Change from baseline in physical examination

    Time frame: Subjects will be followed up to 14 days post-dose

    Physical examination

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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 outcomes

  1. Change from baseline in the One Back test

    Time frame: Week 12

    The One Back test is a measure of working memory

  2. Change from baseline in the Two Back test

    Time frame: Week 12

    The Two Back test is a measure of working memory

  3. 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

  4. Change from baseline in the Identification Test

    Time frame: Week 12

    The Identification test is a measure of visual attention

  5. Change from baseline in the International Shopping List Test

    Time frame: Week 12

    The International Shopping List test is a measure of verbal learning

  6. 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

Sponsors and collaborators

Lead sponsor

Aptinyx

Industry

Collaborators

  • CogState Ltd.
  • Worldwide Clinical Trials

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2019
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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