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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04148391
Recruitment Status : Active, not recruiting
First Posted : November 1, 2019
Last Update Posted : October 27, 2022
Sponsor:
Collaborators:
CogState Ltd.
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 1, 2019
Last Update Posted Date October 27, 2022
Actual Study Start Date  ICMJE November 14, 2019
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
Number of Subjects With Adverse Events [ Time Frame: Subjects will be followed up to 14 days post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
Official Title  ICMJE 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
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Mild Dementia
  • Parkinson Disease
  • Lewy Body Disease
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo Capsules
    Intervention: Drug: Placebo Oral Capsule
  • Experimental: NYX-458 30 mg
    Single oral dose taken daily for 12 weeks.
    Intervention: Drug: NYX-458
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 26, 2022)
99
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
135
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04148391
Other Study ID Numbers  ICMJE NYX-458-2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Aptinyx
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aptinyx
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • CogState Ltd.
  • Worldwide Clinical Trials
Investigators  ICMJE Not Provided
PRS Account Aptinyx
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP