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

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 Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Mild Cognitive Impairment; Lewy Body Disease; Mild Dementia
• Intervention / Treatment: Drug: Placebo Oral Capsule; Drug: NYX-458

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Aptinyx Clinical Site
  • California
    • Fresno, California, United States, 93710
      • Aptinyx Clinical Site
    • Simi Valley, California, United States, 93065
      • Aptinyx Clinical Site
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Aptinyx Clinical Site
    • Bradenton, Florida, United States, 34209
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33122
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33165
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33173
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33176
      • Aptinyx Clinical Site
    • Miami Lakes, Florida, United States, 33016
      • Aptinyx Clinical Site
    • Orlando, Florida, United States, 32819
      • Aptinyx Clinical Site
    • Port Charlotte, Florida, United States, 33980
      • Aptinyx Clinical Site
    • Port Orange, Florida, United States, 32127
      • Aptinyx Clinical Site
    • Sunrise, Florida, United States, 33351
      • Aptinyx Clinical Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Aptinyx Clinical Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Aptinyx Clinical Site
  • Minnesota
    • Golden Valley, Minnesota, United States, 55427
      • Aptinyx Clinical Site
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Aptinyx Clinical Site
  • New York
    • Poughkeepsie, New York, United States, 12601
      • Aptinyx Clinical Site
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Aptinyx Clinical Site
  • Ohio
    • Dayton, Ohio, United States, 45459
      • Aptinyx Clinical Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Aptinyx Clinical Site
  • Texas
    • Round Rock, Texas, United States, 78681
      • Aptinyx Clinical Site
    • Sugar Land, Texas, United States, 77478
      • Aptinyx Clinical Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Aptinyx Clinical Site
    • Spokane, Washington, United States, 99202
      • Aptinyx Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo Capsules	Drug: Placebo Oral Capsule; Matching placebo capsules.
Experimental: NYX-458 30 mg; Single oral dose taken daily for 12 weeks.	Drug: NYX-458; NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in physical examination	Physical examination	Subjects will be followed up to 14 days post-dose
Rates of adverse events and serious adverse events	Adverse events and serious adverse events	Subjects will be followed up to 14 days post-dose
Rates of early termination due to adverse events	Early termination due to adverse events	Subjects will be followed up to 14 days post-dose
Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results	Vital signs, clinical laboratory values, and electrocardiogram results	Subjects will be followed up to 14 days post-dose
Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)	Neuropsychiatric Inventory (NPI-12) - NPI-12 assesses 12 behavioral domains common in dementia. Higher scores indicate more severe illness.	Subjects will be followed up to 14 days post-dose
Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS)	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	Subjects will be followed up to 14 days post-dose
Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4	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.	Subjects will be followed up to 14 days post-dose
Change in total score of the Sheehan Suicidality Tracking Scale (S-STS)	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	Subjects will be followed up to 14 days post-dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aptinyx
• Collaborators: CogState Ltd.; Worldwide Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Parkinson Disease; Dementia; Cognitive Dysfunction; Lewy Body Disease
• Other Study ID Numbers: NYX-458-2006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No