Mild Cognitive ImpairmentPhase 2NCT04148391
NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
A Phase 2 study testing NYX-458 in people with Mild Cognitive Impairment and Mild Dementia, run by Aptinyx at 26 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Parkinson Disease
- What is being tested?
- NYX-458
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 26 sitesUnited States
- Study dates
- 14 Nov 2019to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Aptinyx Clinical Site
Asheville, North Carolina, 28806
Aptinyx Clinical Site
Bellevue, Washington, 98007
Aptinyx Clinical Site
Boca Raton, Florida, 33486
Aptinyx Clinical Site
Bradenton, Florida, 34209
Aptinyx Clinical Site
Dayton, Ohio, 45459
Aptinyx Clinical Site
Decatur, Georgia, 30030
Aptinyx Clinical Site
Farmington Hills, Michigan, 48334
Aptinyx Clinical Site
Fresno, California, 93710
Aptinyx Clinical Site
Golden Valley, Minnesota, 55427
Aptinyx Clinical Site
Miami, Florida, 33122
Aptinyx Clinical Site
Miami, Florida, 33165
Aptinyx Clinical Site
Miami, Florida, 33173
Aptinyx Clinical Site
Miami, Florida, 33176
Aptinyx Clinical Site
Miami Lakes, Florida, 33016
Aptinyx Clinical Site
Orlando, Florida, 32819
Aptinyx Clinical Site
Port Charlotte, Florida, 33980
Aptinyx Clinical Site
Port Orange, Florida, 32127
Aptinyx Clinical Site
Poughkeepsie, New York, 12601
Aptinyx Clinical Site
Round Rock, Texas, 78681
Aptinyx Clinical Site
Scottsdale, Arizona, 85258
Aptinyx Clinical Site
Simi Valley, California, 93065
Aptinyx Clinical Site
Spokane, Washington, 99202
Aptinyx Clinical Site
Sugar Land, Texas, 77478
Aptinyx Clinical Site
Sunrise, Florida, 33351
Aptinyx Clinical Site
Toms River, New Jersey, 08755
Aptinyx Clinical Site
Tulsa, Oklahoma, 74136
About this study
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
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
Read the 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.
- Being tested
- Placebo Oral Capsule, NYX-458
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral CapsuleDrug
Matching placebo capsules.
NYX-458Drug
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo Capsules Receives: Drug: Placebo Oral Capsule |
| NYX-458 30 mg | Experimental | Single oral dose taken daily for 12 weeks. Receives: Drug: NYX-458 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical examination
Physical examination
Measured: Subjects will be followed up to 14 days post-dose
Rates of adverse events and serious adverse events
Adverse events and serious adverse events
Measured: Subjects will be followed up to 14 days post-dose
Rates of early termination due to adverse events
Early termination due to adverse events
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Subjects will be followed up to 14 days post-dose
Secondary outcomes (6)
Change from baseline in the One Back test
The One Back test is a measure of working memory
Measured: Week 12
Change from baseline in the Two Back test
The Two Back test is a measure of working memory
Measured: Week 12
Change from baseline in the Groton Maze Learning Test
The Groton Maze Learning test is a measure of problem solving and reasoning
Measured: Week 12
Change from baseline in the Identification Test
The Identification test is a measure of visual attention
Measured: Week 12
Change from baseline in the International Shopping List Test
The International Shopping List test is a measure of verbal learning
Measured: Week 12
Change from baseline on Continuous Paired Associate Learning Test
The Continuous Paired Associate Learning test is a measure of visual associate memory
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start14 Nov 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptinyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CogState Ltd., Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148391
- Sponsor's protocol ID
- NYX-458-2006
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04148391
- Acronym / sponsor ID
- NYX-458-2006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AptinyxIndustry (pharma, biotech, devices)
- Collaborators
- CogState Ltd., Worldwide Clinical Trials
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Oral CapsuleMatching placebo Capsules |
| NYX-458 30 mg | Experimental | Drug: NYX-458Single oral dose taken daily for 12 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Oral CapsuleMatching placebo capsules. | Drug | Placebo |
| NYX-458NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). | Drug | NYX-458 30 mg |
Primary outcome
Change from baseline in physical examination
Time frame: Subjects will be followed up to 14 days post-dose
Physical examination
Rates of adverse events and serious adverse events
Time frame: Subjects will be followed up to 14 days post-dose
Adverse events and serious adverse events
Rates of early termination due to adverse events
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
6 secondary outcomes
Change from baseline in the One Back test
Time frame: Week 12
Change from baseline in the Two Back test
Time frame: Week 12
Change from baseline in the Groton Maze Learning Test
Time frame: Week 12
Change from baseline in the Identification Test
Time frame: Week 12
Change from baseline in the International Shopping List Test
Time frame: Week 12
Change from baseline on Continuous Paired Associate Learning Test
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NYX-458 in people with Mild Cognitive Impairment and Mild Dementia, run by Aptinyx at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in physical examination (time frame: Subjects will be followed up to 14 days post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.