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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

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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Mild Dementia Parkinson Disease Lewy Body Disease Drug: Placebo Oral Capsule Drug: NYX-458 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148391


Locations
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United States, Arizona
Aptinyx Clinical Site
Scottsdale, Arizona, United States, 85258
United States, California
Aptinyx Clinical Site
Fresno, California, United States, 93710
Aptinyx Clinical Site
Simi Valley, California, United States, 93065
United States, Florida
Aptinyx Clinical Site
Boca Raton, Florida, United States, 33486
Aptinyx Clinical Site
Bradenton, Florida, United States, 34209
Aptinyx Clinical Site
Miami Lakes, Florida, United States, 33016
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
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
United States, Georgia
Aptinyx Clinical Site
Decatur, Georgia, United States, 30030
United States, Michigan
Aptinyx Clinical Site
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Aptinyx Clinical Site
Golden Valley, Minnesota, United States, 55427
United States, New Jersey
Aptinyx Clinical Site
Toms River, New Jersey, United States, 08755
United States, New York
Aptinyx Clinical Site
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Aptinyx Clinical Site
Asheville, North Carolina, United States, 28806
United States, Ohio
Aptinyx Clinical Site
Dayton, Ohio, United States, 45459
United States, Oklahoma
Aptinyx Clinical Site
Tulsa, Oklahoma, United States, 74136
United States, Texas
Aptinyx Clinical Site
Round Rock, Texas, United States, 78681
Aptinyx Clinical Site
Sugar Land, Texas, United States, 77478
United States, Washington
Aptinyx Clinical Site
Bellevue, Washington, United States, 98007
Aptinyx Clinical Site
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Aptinyx
CogState Ltd.
Worldwide Clinical Trials
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Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04148391    
Other Study ID Numbers: NYX-458-2006
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Lewy Body Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders