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NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)

Primary Purpose

Mild Cognitive Impairment, Mild Dementia, Parkinson Disease

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo Oral Capsule

NYX-458

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

NYX-458 30 mg

Arm Description

Matching placebo Capsules

Single oral dose taken daily for 12 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in physical examination

Physical examination

Rates of adverse events and serious adverse events

Adverse events and serious adverse events

Rates of early termination due to adverse events

Early termination due to adverse events

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

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)

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)

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

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)

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

Secondary Outcome Measures

Change from baseline in the One Back test

The One Back test is a measure of working memory

Change from baseline in the Two Back test

The Two Back test is a measure of working memory

Change from baseline in the Groton Maze Learning Test

The Groton Maze Learning test is a measure of problem solving and reasoning

Change from baseline in the Identification Test

The Identification test is a measure of visual attention

Change from baseline in the International Shopping List Test

The International Shopping List test is a measure of verbal learning

Change from baseline on Continuous Paired Associate Learning Test

The Continuous Paired Associate Learning test is a measure of visual associate memory

Full Information

NCT ID

NCT04148391

First Posted

October 30, 2019

Last Updated

October 26, 2022

Sponsor

Aptinyx

Collaborators

CogState Ltd., Worldwide Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT04148391

Brief Title

NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 14, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aptinyx

Collaborators

CogState Ltd., Worldwide Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Mild Dementia, Parkinson Disease, Lewy Body Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo Capsules

Arm Title

NYX-458 30 mg

Arm Type

Experimental

Arm Description

Single oral dose taken daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Capsule

Intervention Description

Matching placebo capsules.

Intervention Type

Drug

Intervention Name(s)

NYX-458

Intervention Description

NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Primary Outcome Measure Information:

Title

Change from baseline in physical examination

Description

Physical examination

Time Frame