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

NCT04148391 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: NYX-458-2006
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 26

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

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Change from baseline in physical examination

  Physical examination

  Subjects will be followed up to 14 days post-dose

• Rates of adverse events and serious adverse events

  Adverse events and serious adverse events

  Subjects will be followed up to 14 days post-dose

• Rates of early termination due to adverse events

  Early termination due to adverse events

  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

  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.

  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

  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

  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.

  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

  Subjects will be followed up to 14 days post-dose

Secondary Outcomes (6)

• Change from baseline in the One Back test

  Week 12

• Change from baseline in the Two Back test

  Week 12

• Change from baseline in the Groton Maze Learning Test

  Week 12

• Change from baseline in the Identification Test

  Week 12

• Change from baseline in the International Shopping List Test

  Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching placebo Capsules

Drug: Placebo Oral Capsule

NYX-458 30 mg

EXPERIMENTAL

Single oral dose taken daily for 12 weeks.

Drug: NYX-458

Interventions

Placebo Oral Capsule DRUG

Matching placebo capsules.

Placebo

NYX-458 DRUG

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

NYX-458 30 mg

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aptinyx: lead
• CogState Ltd.: collaborator
• Worldwide Clinical Trials: collaborator

Study Sites (26)

Aptinyx Clinical Site

Scottsdale, Arizona, 85258, United States

Location

Aptinyx Clinical Site

Fresno, California, 93710, United States

Location

Aptinyx Clinical Site

Simi Valley, California, 93065, United States

Location

Aptinyx Clinical Site

Boca Raton, Florida, 33486, United States

Location

Aptinyx Clinical Site

Bradenton, Florida, 34209, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33122, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33165, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33173, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33176, United States

Location

Aptinyx Clinical Site

Miami Lakes, Florida, 33016, United States

Location

Aptinyx Clinical Site

Orlando, Florida, 32819, United States

Location

Aptinyx Clinical Site

Port Charlotte, Florida, 33980, United States

Location

Aptinyx Clinical Site

Port Orange, Florida, 32127, United States

Location

Aptinyx Clinical Site

Sunrise, Florida, 33351, United States

Location

Aptinyx Clinical Site

Decatur, Georgia, 30030, United States

Location

Aptinyx Clinical Site

Farmington Hills, Michigan, 48334, United States

Location

Aptinyx Clinical Site

Golden Valley, Minnesota, 55427, United States

Location

Aptinyx Clinical Site

Toms River, New Jersey, 08755, United States

Location

Aptinyx Clinical Site

Poughkeepsie, New York, 12601, United States

Location

Aptinyx Clinical Site

Asheville, North Carolina, 28806, United States

Location

Aptinyx Clinical Site

Dayton, Ohio, 45459, United States

Location

Aptinyx Clinical Site

Tulsa, Oklahoma, 74136, United States

Location

Aptinyx Clinical Site

Round Rock, Texas, 78681, United States

Location

Aptinyx Clinical Site

Sugar Land, Texas, 77478, United States

Location

Aptinyx Clinical Site

Bellevue, Washington, 98007, United States

Location

Aptinyx Clinical Site

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease; Lewy Body Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: November 14, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)