A Study to Evaluate NYX-458 in Subjects With PD-MCI
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Mild Cognitive Impairment | Drug: Placebo Oral Capsule Drug: NYX-458 | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Matching placebo Capsules
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Drug: Placebo Oral Capsule
Matching placebo capsules. |
Experimental: NYX-458 10 mg
Single oral dose taken daily for 12 weeks.
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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). |
- Number of Subjects With Adverse Events [ Time Frame: Subjects will be followed up to 14 days post-dose ]Adverse Events

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

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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |