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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04148391
• Other study ID #: NYX-458-2006
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 14, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2022
• Source: Aptinyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Lewy Body Disease
• Mild Cognitive Impairment
• Mild Dementia
• Parkinson Disease

Intervention

Drug:
• Placebo Oral Capsule
Matching placebo capsules.
• NYX-458
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Locations

Country	Name	City	State
United States	Aptinyx Clinical Site	Asheville	North Carolina
United States	Aptinyx Clinical Site	Bellevue	Washington
United States	Aptinyx Clinical Site	Boca Raton	Florida
United States	Aptinyx Clinical Site	Bradenton	Florida
United States	Aptinyx Clinical Site	Dayton	Ohio
United States	Aptinyx Clinical Site	Decatur	Georgia
United States	Aptinyx Clinical Site	Farmington Hills	Michigan
United States	Aptinyx Clinical Site	Fresno	California
United States	Aptinyx Clinical Site	Golden Valley	Minnesota
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	Miami Lakes	Florida
United States	Aptinyx Clinical Site	Orlando	Florida
United States	Aptinyx Clinical Site	Port Charlotte	Florida
United States	Aptinyx Clinical Site	Port Orange	Florida
United States	Aptinyx Clinical Site	Poughkeepsie	New York
United States	Aptinyx Clinical Site	Round Rock	Texas
United States	Aptinyx Clinical Site	Scottsdale	Arizona
United States	Aptinyx Clinical Site	Simi Valley	California
United States	Aptinyx Clinical Site	Spokane	Washington
United States	Aptinyx Clinical Site	Sugar Land	Texas
United States	Aptinyx Clinical Site	Sunrise	Florida
United States	Aptinyx Clinical Site	Toms River	New Jersey
United States	Aptinyx Clinical Site	Tulsa	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
Aptinyx	CogState Ltd., Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in physical examination	Physical examination	Subjects will be followed up to 14 days post-dose
Primary	Rates of adverse events and serious adverse events	Adverse events and serious adverse events	Subjects will be followed up to 14 days post-dose
Primary	Rates of early termination due to adverse events	Early termination due to adverse events	Subjects will be followed up to 14 days post-dose
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change from baseline in the One Back test	The One Back test is a measure of working memory	Week 12
Secondary	Change from baseline in the Two Back test	The Two Back test is a measure of working memory	Week 12
Secondary	Change from baseline in the Groton Maze Learning Test	The Groton Maze Learning test is a measure of problem solving and reasoning	Week 12
Secondary	Change from baseline in the Identification Test	The Identification test is a measure of visual attention	Week 12
Secondary	Change from baseline in the International Shopping List Test	The International Shopping List test is a measure of verbal learning	Week 12
Secondary	Change from baseline on Continuous Paired Associate Learning Test	The Continuous Paired Associate Learning test is a measure of visual associate memory	Week 12