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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04148391
Other study ID # NYX-458-2006
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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