← Back to Search

Other

NYX-458 for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by Aptinyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be followed up to 14 days post-dose
Awards & highlights

Study Summary

This trial will test the effects of NYX-458 on mild cognitive impairment, mild dementia, and prodromal or manifest Lewy body dementia.

Eligible Conditions
  • Parkinson's Disease
  • Mild Cognitive Impairment
  • Lewy Body Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a CGI-S score of at least 3 (mildly ill).
Select...
You have a study partner who can accompany the subject at specified study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be followed up to 14 days post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be followed up to 14 days post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)
Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4
Change from baseline in physical examination
+5 more
Secondary outcome measures
Change from baseline in the Groton Maze Learning Test
Change from baseline in the Identification Test
Change from baseline in the International Shopping List Test
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NYX-458 30 mgExperimental Treatment1 Intervention
Single oral dose taken daily for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo Capsules

Find a Location

Who is running the clinical trial?

CogState Ltd.Industry Sponsor
7 Previous Clinical Trials
314 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
60 Previous Clinical Trials
14,288 Total Patients Enrolled
AptinyxLead Sponsor
8 Previous Clinical Trials
1,235 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if people who are below the age of 25 can participate in this research project?

"According to the screening process for this study, the minimum age an individual can be is 50 and the maximum is 80."

Answered by AI

What are the aims of this scientific investigation?

"The main objective of this study, which will be measured over a 14-day period after subjects receive the medication, is to assess rates of adverse events and serious adverse events. Additionally, this study will also look at secondary outcomes like change from baseline on the Two Back test (a measure of working memory), the Groton Maze Learning Test (a measure of problem solving and reasoning), and the Continuous Paired Associate Learning Test (a measure of visual associate memory)."

Answered by AI

Is this research program still recruiting new participants?

"No, this particular study is not looking for any more participants. Although, there are 1393 other trials with open recruitment at the moment. This trial was first posted on November 14th, 2019 and updated last on October 26th, 2022."

Answered by AI

Are there any dangers to taking NYX-458?

"While there is some evidence of safety from clinical trials, none of the data collected supports efficacy. Consequently, our team has given NYX-458 a score of 2."

Answered by AI

Does this medical study have any specific requirements for participants?

"This clinical trial is looking for 99 people with parkinson disease between the ages of 50 and 80. Most notable, patients should meet the following criteria: Has a study partner who can accompany the subject at specified study visits, 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"

Answered by AI

How many different hospitals or research centers are participating in this trial?

"Patients are currently being enrolled at this clinical trial's 31 sites which include locations in Decatur, Spokane and West Bloomfield. To limit travel for participants, it is best to select a clinic that is close to your location."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Michigan
California
Other
How old are they?
18 - 65
65+
What site did they apply to?
Aptinyx Clinical Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~19 spots leftby Mar 2025