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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Matching placebo capsules.
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Aptinyx Clinical Site
Scottsdale, Arizona, United States
Change from baseline in physical examination
Physical examination
Time frame: Subjects will be followed up to 14 days post-dose
Rates of adverse events and serious adverse events
Adverse events and serious adverse events
Time frame: Subjects will be followed up to 14 days post-dose
Rates of early termination due to adverse events
Early termination due to adverse events
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Subjects will be followed up to 14 days post-dose
Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4
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Aptinyx Clinical Site
Fresno, California, United States
Aptinyx Clinical Site
Simi Valley, California, United States
Aptinyx Clinical Site
Boca Raton, Florida, United States
Aptinyx Clinical Site
Bradenton, Florida, United States
Aptinyx Clinical Site
Miami, Florida, United States
Aptinyx Clinical Site
Miami, Florida, United States
Aptinyx Clinical Site
Miami, Florida, United States
Aptinyx Clinical Site
Miami, Florida, United States
Aptinyx Clinical Site
Miami Lakes, Florida, United States
...and 16 more locations
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.
Time frame: 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
Time frame: Subjects will be followed up to 14 days post-dose
Change from baseline in the One Back test
The One Back test is a measure of working memory
Time frame: Week 12
Change from baseline in the Two Back test
The Two Back test is a measure of working memory
Time frame: Week 12
Change from baseline in the Groton Maze Learning Test
The Groton Maze Learning test is a measure of problem solving and reasoning
Time frame: Week 12
Change from baseline in the Identification Test
The Identification test is a measure of visual attention
Time frame: Week 12
Change from baseline in the International Shopping List Test
The International Shopping List test is a measure of verbal learning
Time frame: Week 12
Change from baseline on Continuous Paired Associate Learning Test
The Continuous Paired Associate Learning test is a measure of visual associate memory
Time frame: Week 12