Clinical Trials in the USA / NCT04148391
Active, not recruiting
Phase 2
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 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Mild Cognitive ImpairmentMild DementiaParkinson DiseaseLewy Body Disease
Investigational drug(s) / intervention(s)
Placebo Oral CapsuleNYX-458
Placebo Oral Capsule: Matching placebo capsules.
NYX-458: NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Study 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
Eligibility
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.
Primary outcome measure(s)
- Change from baseline in physical examination — Subjects will be followed up to 14 days post-dose
Physical examination - Rates of adverse events and serious adverse events — Subjects will be followed up to 14 days post-dose
Adverse events and serious adverse events - Rates of early termination due to adverse events — 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 — 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) — 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) — 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 — 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) — 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
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Aptinyx Clinical Site | Scottsdale | Arizona | |
| Aptinyx Clinical Site | Fresno | California | |
| Aptinyx Clinical Site | Simi Valley | California | |
| Aptinyx Clinical Site | Boca Raton | Florida | |
| Aptinyx Clinical Site | Bradenton | Florida | |
| Aptinyx Clinical Site | Miami | Florida | |
| Aptinyx Clinical Site | Miami | Florida | |
| Aptinyx Clinical Site | Miami | Florida | |
| Aptinyx Clinical Site | Miami | Florida | |
| Aptinyx Clinical Site | Miami Lakes | Florida | |
| Aptinyx Clinical Site | Orlando | Florida | |
| Aptinyx Clinical Site | Port Charlotte | Florida | |
| Aptinyx Clinical Site | Port Orange | Florida | |
| Aptinyx Clinical Site | Sunrise | Florida | |
| Aptinyx Clinical Site | Decatur | Georgia | |
| Aptinyx Clinical Site | Farmington Hills | Michigan | |
| Aptinyx Clinical Site | Golden Valley | Minnesota | |
| Aptinyx Clinical Site | Toms River | New Jersey | |
| Aptinyx Clinical Site | Poughkeepsie | New York | |
| Aptinyx Clinical Site | Asheville | North Carolina | |
| Aptinyx Clinical Site | Dayton | Ohio | |
| Aptinyx Clinical Site | Tulsa | Oklahoma | |
| Aptinyx Clinical Site | Round Rock | Texas | |
| Aptinyx Clinical Site | Sugar Land | Texas | |
| Aptinyx Clinical Site | Bellevue | Washington | |
| Aptinyx Clinical Site | Spokane | Washington |
Other trials for the same condition
Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
Active, not recruiting
A Novel Computer-Based Functional Skills Assessment and Training Program
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04148391 on ClinicalTrials.gov ↗ ← All trials in the USA