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A Study to Evaluate NYX-458 in Subjects With PD-MCI

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 : December 22, 2020
Sponsor:
Collaborators:
CogState Ltd.
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx

Study Description
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Brief Summary:
To evaluate the safety and tolerability of NYX-458 in mild cognitive impairments associated with Parkinson's disease and explore the potential benefit in cognition.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Mild Cognitive Impairment 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 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 Associated With Parkinson's Disease
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo Capsules
 Drug: Placebo Oral Capsule
Matching placebo capsules.
Experimental: NYX-458 10 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).
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).
Experimental: NYX-458 100 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).


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Adverse Events [ Time Frame: Subjects will be followed up to 14 days post-dose ]
    Adverse Events


Eligibility Criteria
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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:

  • A primary diagnosis of mild cognitive impairment associated with Parkinson's Disease
  • Montreal Cognitive Assessment ≥ 17
  • Modified Hoehn and Yahr Stage 1 to 3, Inclusive
  • Stable anti-parkinsonian regimen
  • Has a study partner who can accompany the subject at specified study visits

Exclusion Criteria:

  • Clinically meaningful motor complications
  • Meets criteria for dementia
  • Current use of medications with primarily central nervous system activities
  • Other clinically significant medical histories that may interfere with completing the study.
Contacts and Locations
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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
Oxnard, California, United States, 93030
Aptinyx Clinical Site
Pasadena, California, United States, 91105
Aptinyx Clinical Site
Reseda, California, United States, 91335
Aptinyx Clinical Site
Simi Valley, California, United States, 93065
United States, Connecticut
Aptinyx Clinical Site
New London, Connecticut, United States, 06320
United States, Florida
Aptinyx Clinical Site
Boca Raton, Florida, United States, 33486
Aptinyx Clinical Site
Hallandale Beach, Florida, United States, 33009
Aptinyx Clinical Site
Hialeah, Florida, United States, 33016
Aptinyx Clinical Site
Miami, Florida, United States, 33122
Aptinyx Clinical Site
Miami, Florida, United States, 33174
Aptinyx Clinical Site
Miami, Florida, United States, 33175
Aptinyx Clinical Site
Sunrise, Florida, United States, 33351
United States, Georgia
Aptinyx Clinical Site
Decatur, Georgia, United States, 30033
United States, Michigan
Aptinyx Clinical Site
Farmington Hills, Michigan, United States, 48334
Aptinyx Clinical Site
West Bloomfield, Michigan, United States, 48322
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, North Carolina
Aptinyx Clincial Site
Asheville, North Carolina, United States, 28806
United States, Ohio
Aptinyx Clinical Site
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Aptinyx Clinical Site
Tulsa, Oklahoma, United States, 74136
United States, Texas
Aptinyx Clinical Site
Sugar Land, Texas, United States, 77478
Sponsors and Collaborators
Aptinyx
CogState Ltd.
Worldwide Clinical Trials
More Information
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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: December 22, 2020
Last Verified: December 2020
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
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders