NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
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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 : October 27, 2022
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Condition or disease | Intervention/treatment | Phase |
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Mild Cognitive Impairment Mild Dementia Parkinson Disease Lewy Body Disease | Drug: Placebo Oral Capsule Drug: NYX-458 | Phase 2 |
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 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Matching placebo Capsules
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Drug: Placebo Oral Capsule
Matching placebo capsules. |
Experimental: NYX-458 30 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). |
- 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
- 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

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:
- 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.

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