Lewy Body Disease, Mild Cognitive Impairment, Mild Dementia, Parkinson Disease
Conditions
Brief 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
Detailed description
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.
Interventions
DRUGPlacebo Oral Capsule
Matching placebo capsules.
DRUGNYX-458
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Sponsors
CogState Ltd.
Worldwide Clinical Trials
Aptinyx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 from baseline in physical examination | Subjects will be followed up to 14 days post-dose | Physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Two Back test | Week 12 | The Two Back test is a measure of working memory |
| Change from baseline in the Groton Maze Learning Test | Week 12 | The Groton Maze Learning test is a measure of problem solving and reasoning |
| Change from baseline in the Identification Test | Week 12 | The Identification test is a measure of visual attention |
| Change from baseline in the International Shopping List Test | Week 12 | The International Shopping List test is a measure of verbal learning |
| Change from baseline on Continuous Paired Associate Learning Test | Week 12 | The Continuous Paired Associate Learning test is a measure of visual associate memory |
| Change from baseline in the One Back test | Week 12 | The One Back test is a measure of working memory |
Countries
United States
Outcome results
None listed