Trial · NCT04148391
NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
NCT04148391, Phase 2, Active not recruiting, Aptinyx
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking). Trials, record NCT04148391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04148391
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
- NCT number
- NCT04148391
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 99 participants, actual
- Lead sponsor
- Aptinyx
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Parkinson Disease, Lewy Body Disease
- Interventions
- Placebo Oral Capsule, NYX-458
- First posted
- 2019-11-01
- Last updated
- 2022-10-27
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in physical examination | Subjects will be followed up to 14 days post-dose | Physical examination |
| Primary | Rates of adverse events and serious adverse events | Subjects will be followed up to 14 days post-dose | Adverse events and serious adverse events |
| Primary | Rates of early termination due to adverse events | Subjects will be followed up to 14 days post-dose | Early termination due to adverse events |
| Primary | Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results | Subjects will be followed up to 14 days post-dose | Vital signs, clinical laboratory values, and electrocardiogram results |
| Primary | Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12) | 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. |
| Primary | Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS) | 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 |
| Primary | Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4 | 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. |
| Primary | Change in total score of the Sheehan Suicidality Tracking Scale (S-STS) | 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 | Change from baseline in the One Back test | Week 12 | The One Back test is a measure of working memory |
| Secondary | Change from baseline in the Two Back test | Week 12 | The Two Back test is a measure of working memory |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Hidden Path Learning | Secondary outcome | ConductCognition |
| Paired Associate Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04148391
GET https://conductscience.org/api/trials/v1/NCT04148391/registered