Active not recruitingPhase 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)

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

Lead sponsor

Aptinyx

Asset

NYX-458

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•Study partner/caregiver required

Primary endpoints

•Physical examination•Rates of adverse events and serious adverse events•Rates of early termination due to adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04148391

Org study IDNYX-458-2006

Timeline

Milestones

Study first posted2019-11-01actual

Study start2019-11-14actual

Last update posted2022-10-27actual

Primary completion2022-12-30estimated

Study completion2022-12-30estimated

Assets

Drug assets

NYX-458

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Memory

Other (unclassified)

Behavior / neuropsychiatric

Global cognition

Executive function / language

Global cognition

1 endpoint

Secondary/protocol endpoint

Change from baseline in the Groton Maze Learning Test

Time frame:Week 12

change from baseline, improvement

Memory

3 endpoints

Secondary/protocol endpoint

Change from baseline in the One Back test

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in the Two Back test

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on Continuous Paired Associate Learning Test

Time frame:Week 12

change from baseline, improvement

Executive function / language

1 endpoint

Secondary/protocol endpoint

Change from baseline in the Identification Test

Time frame:Week 12

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)

Time frame:Subjects will be followed up to 14 days post-dose

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/protocol endpoint

Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS)

Time frame:Subjects will be followed up to 14 days post-dose

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Rates of adverse events and serious adverse events

Time frame:Subjects will be followed up to 14 days post-dose

event count, event

Primary/protocol endpoint

Rates of early termination due to adverse events

Time frame:Subjects will be followed up to 14 days post-dose

event count, event

Primary/protocol endpoint

Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results

Time frame:Subjects will be followed up to 14 days post-dose

change from baseline, event

Primary/protocol endpoint

Change in total score of the Sheehan Suicidality Tracking Scale (S-STS)

Time frame:Subjects will be followed up to 14 days post-dose

change from baseline, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Change from baseline in physical examination

Time frame:Subjects will be followed up to 14 days post-dose

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4

Time frame:Subjects will be followed up to 14 days post-dose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in the International Shopping List Test

Time frame:Week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.