NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
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
Sex
ALL
Min age
50 Years
Max age
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.
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
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.
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