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

Sponsor

Aptinyx (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04148391

Collaborator

CogState Ltd. (Industry), Worldwide Clinical Trials (Other)

100

Enrollment

Locations

Arms

37.5

Anticipated Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Mild Dementia Parkinson Disease Lewy Body Disease	Drug: Placebo Oral Capsule Drug: NYX-458	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 14, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Matching placebo Capsules	Drug: Placebo Oral Capsule Matching placebo capsules.
Experimental: NYX-458 30 mg Single oral dose taken daily for 12 weeks.	Drug: NYX-458 NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Matching placebo Capsules

Drug: Placebo Oral Capsule

Matching placebo capsules.

Experimental: NYX-458 30 mg

Single oral dose taken daily for 12 weeks.

Drug: NYX-458

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

Outcome Measures

Primary Outcome Measures

Change from baseline in physical examination [Subjects will be followed up to 14 days post-dose]
Physical examination
Rates of adverse events and serious adverse events [Subjects will be followed up to 14 days post-dose]
Adverse events and serious adverse events
Rates of early termination due to adverse events [Subjects will be followed up to 14 days post-dose]
Early termination due to adverse events
Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results [Subjects will be followed up to 14 days post-dose]
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) [Subjects will be followed up to 14 days post-dose]
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) [Subjects will be followed up to 14 days post-dose]
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 [Subjects will be followed up to 14 days post-dose]
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) [Subjects will be followed up to 14 days post-dose]
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 [Week 12]
The One Back test is a measure of working memory
Change from baseline in the Two Back test [Week 12]
The Two Back test is a measure of working memory
Change from baseline in the Groton Maze Learning Test [Week 12]
The Groton Maze Learning test is a measure of problem solving and reasoning
Change from baseline in the Identification Test [Week 12]
The Identification test is a measure of visual attention
Change from baseline in the International Shopping List Test [Week 12]
The International Shopping List test is a measure of verbal learning
Change from baseline on Continuous Paired Associate Learning Test [Week 12]
The Continuous Paired Associate Learning test is a measure of visual associate memory

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aptinyx Clinical Site	Scottsdale	Arizona	United States	85258
2	Aptinyx Clinical Site	Fresno	California	United States	93710
3	Aptinyx Clinical Site	Simi Valley	California	United States	93065
4	Aptinyx Clinical Site	New London	Connecticut	United States	06320
5	Aptinyx Clinical Site	Boca Raton	Florida	United States	33486
6	Aptinyx Clinical Site	Bradenton	Florida	United States	34209
7	Aptinyx Clinical Site	Miami Lakes	Florida	United States	33016
8	Aptinyx Clinical Site	Miami	Florida	United States	33122
9	Aptinyx Clinical Site	Miami	Florida	United States	33165
10	Aptinyx Clinical Site	Miami	Florida	United States	33173
11	Aptinyx Clinical Site	Miami	Florida	United States	33176
12	Aptinyx Clinical Site	Orlando	Florida	United States	32819
13	Aptinyx Clinical Site	Port Charlotte	Florida	United States	33980
14	Aptinyx Clinical Site	Port Orange	Florida	United States	32127
15	Aptinyx Clinical Site	Sunrise	Florida	United States	33351
16	Aptinyx Clinical Site	Decatur	Georgia	United States	30030
17	Aptinyx Clinical Site	Farmington Hills	Michigan	United States	48334
18	Aptinyx Clinical Site	Golden Valley	Minnesota	United States	55427
19	Aptinyx Clinical Site	Toms River	New Jersey	United States	08755
20	Aptinyx Clinical Site	Poughkeepsie	New York	United States	12601
21	Aptinyx Clinical Site	Asheville	North Carolina	United States	28806
22	Aptinyx Clinical Site	Dayton	Ohio	United States	45459
23	Aptinyx Clinical Site	Tulsa	Oklahoma	United States	74136
24	Aptinyx Clinical Site	Port Royal	South Carolina	United States	29935
25	Aptinyx Clinical Site	Round Rock	Texas	United States	78681
26	Aptinyx Clinical Site	Sugar Land	Texas	United States	77478
27	Aptinyx Clinical Site	Bellevue	Washington	United States	98007
28	Aptinyx Clinical Site	Spokane	Washington	United States	99202

Sponsors and Collaborators

Aptinyx
CogState Ltd.
Worldwide Clinical Trials

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aptinyx

ClinicalTrials.gov Identifier:

NCT04148391

Other Study ID Numbers:

NYX-458-2006

First Posted:

Nov 1, 2019

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Dementia

Lewy Body Disease

Cognitive Dysfunction

Study Results

No Results Posted as of Jun 8, 2022