NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
NCT ID: NCT04148391
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
99 participants
INTERVENTIONAL
2019-11-14
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Matching placebo Capsules
Placebo Oral Capsule
Matching placebo capsules.
NYX-458 30 mg
Single oral dose taken daily for 12 weeks.
NYX-458
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Interventions
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Placebo Oral Capsule
Matching placebo capsules.
NYX-458
NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Eligibility Criteria
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Inclusion Criteria
* 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
* Current use of medications with primarily central nervous system activities
* Other clinically significant medical histories that may interfere with completing the study.
50 Years
80 Years
ALL
No
Sponsors
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CogState Ltd.
INDUSTRY
Worldwide Clinical Trials
OTHER
Aptinyx
INDUSTRY
Responsible Party
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Locations
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Aptinyx Clinical Site
Scottsdale, Arizona, United States
Aptinyx Clinical Site
Fresno, California, United States
Aptinyx Clinical Site
Simi Valley, California, United States
Aptinyx Clinical Site
Boca Raton, Florida, United States
Aptinyx Clinical Site
Bradenton, 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, 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
Sunrise, Florida, United States
Aptinyx Clinical Site
Decatur, Georgia, United States
Aptinyx Clinical Site
Farmington Hills, Michigan, United States
Aptinyx Clinical Site
Golden Valley, Minnesota, United States
Aptinyx Clinical Site
Toms River, New Jersey, United States
Aptinyx Clinical Site
Poughkeepsie, New York, United States
Aptinyx Clinical Site
Asheville, North Carolina, United States
Aptinyx Clinical Site
Dayton, Ohio, United States
Aptinyx Clinical Site
Tulsa, Oklahoma, United States
Aptinyx Clinical Site
Round Rock, Texas, United States
Aptinyx Clinical Site
Sugar Land, Texas, United States
Aptinyx Clinical Site
Bellevue, Washington, United States
Aptinyx Clinical Site
Spokane, Washington, United States
Countries
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Other Identifiers
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NYX-458-2006
Identifier Type: -
Identifier Source: org_study_id
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