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

October 26, 2022 updated by: Aptinyx

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in physical examination
Time Frame: Subjects will be followed up to 14 days post-dose
Physical examination
Subjects will be followed up to 14 days post-dose
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
Subjects will be followed up to 14 days post-dose
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
Subjects will be followed up to 14 days post-dose
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
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)
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.
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)
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
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
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.
Subjects will be followed up to 14 days post-dose
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
Subjects will be followed up to 14 days post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the One Back test
Time Frame: Week 12
The One Back test is a measure of working memory
Week 12
Change from baseline in the Two Back test
Time Frame: Week 12
The Two Back test is a measure of working memory
Week 12
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
Week 12
Change from baseline in the Identification Test
Time Frame: Week 12
The Identification test is a measure of visual attention
Week 12
Change from baseline in the International Shopping List Test
Time Frame: Week 12
The International Shopping List test is a measure of verbal learning
Week 12
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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aptinyx

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CogState Ltd.
Worldwide Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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