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| Name | Class |
|---|---|
| CogState Ltd. | INDUSTRY |
| Worldwide Clinical Trials | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo Capsules |
|
| NYX-458 30 mg | Experimental | Single oral dose taken daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Capsule | Drug | Matching placebo capsules. |
| |
| NYX-458 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in physical examination | Physical examination | Subjects will be followed up to 14 days post-dose |
| Rates of adverse events and serious adverse events | Adverse events and serious adverse events | Subjects will be followed up to 14 days post-dose |
| Rates of early termination due to adverse events | Early termination due to adverse events | Subjects will be followed up to 14 days post-dose |
| Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results | Vital signs, clinical laboratory values, and electrocardiogram results | Subjects will be followed up to 14 days post-dose |
| Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12) | Neuropsychiatric Inventory (NPI-12) - NPI-12 assesses 12 behavioral domains common in dementia. Higher scores indicate more severe illness. | Subjects will be followed up to 14 days post-dose |
| Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS) | 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 | Subjects will be followed up to 14 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the One Back test | The One Back test is a measure of working memory | Week 12 |
| Change from baseline in the Two Back test | The Two Back test is a measure of working memory |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aptinyx Clinical Site | Scottsdale | Arizona | 85258 | United States | ||
| Aptinyx Clinical Site |
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| Drug |
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). |
|
| Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4 |
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. |
| Subjects will be followed up to 14 days post-dose |
| Change in total score of the Sheehan Suicidality Tracking Scale (S-STS) | 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 | Subjects will be followed up to 14 days post-dose |
| Week 12 |
| Change from baseline in the Groton Maze Learning Test | The Groton Maze Learning test is a measure of problem solving and reasoning | Week 12 |
| Change from baseline in the Identification Test | The Identification test is a measure of visual attention | Week 12 |
| Change from baseline in the International Shopping List Test | The International Shopping List test is a measure of verbal learning | Week 12 |
| Change from baseline on Continuous Paired Associate Learning Test | The Continuous Paired Associate Learning test is a measure of visual associate memory | Week 12 |
| Fresno |
| California |
| 93710 |
| United States |
| Aptinyx Clinical Site | Simi Valley | California | 93065 | United States |
| Aptinyx Clinical Site | Boca Raton | Florida | 33486 | United States |
| Aptinyx Clinical Site | Bradenton | Florida | 34209 | United States |
| Aptinyx Clinical Site | Miami | Florida | 33122 | United States |
| Aptinyx Clinical Site | Miami | Florida | 33165 | United States |
| Aptinyx Clinical Site | Miami | Florida | 33173 | United States |
| Aptinyx Clinical Site | Miami | Florida | 33176 | United States |
| Aptinyx Clinical Site | Miami Lakes | Florida | 33016 | United States |
| Aptinyx Clinical Site | Orlando | Florida | 32819 | United States |
| Aptinyx Clinical Site | Port Charlotte | Florida | 33980 | United States |
| Aptinyx Clinical Site | Port Orange | Florida | 32127 | United States |
| Aptinyx Clinical Site | Sunrise | Florida | 33351 | United States |
| Aptinyx Clinical Site | Decatur | Georgia | 30030 | United States |
| Aptinyx Clinical Site | Farmington Hills | Michigan | 48334 | United States |
| Aptinyx Clinical Site | Golden Valley | Minnesota | 55427 | United States |
| Aptinyx Clinical Site | Toms River | New Jersey | 08755 | United States |
| Aptinyx Clinical Site | Poughkeepsie | New York | 12601 | United States |
| Aptinyx Clinical Site | Asheville | North Carolina | 28806 | United States |
| Aptinyx Clinical Site | Dayton | Ohio | 45459 | United States |
| Aptinyx Clinical Site | Tulsa | Oklahoma | 74136 | United States |
| Aptinyx Clinical Site | Round Rock | Texas | 78681 | United States |
| Aptinyx Clinical Site | Sugar Land | Texas | 77478 | United States |
| Aptinyx Clinical Site | Bellevue | Washington | 98007 | United States |
| Aptinyx Clinical Site | Spokane | Washington | 99202 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 15, 2023 | Apr 6, 2023 | 46 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D010300 | Parkinson Disease |
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
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