Clinical trial NCT04148391: NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Mild Dementia
Parkinson Disease
Lewy Body Disease
Lead sponsor: Aptinyx
Sponsor class: INDUSTRY
Collaborators: name: CogState Ltd.
name: Worldwide Clinical Trials
First posted: 2019-11-01
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in physical examination
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Rates of adverse events and serious adverse events
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Rates of early termination due to adverse events
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS)
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4
timeFrame: Subjects will be followed up to 14 days post-dose
measure: Change in total score of the Sheehan Suicidality Tracking Scale (S-STS)
timeFrame: Subjects will be followed up to 14 days post-dose
Secondary outcomes:
measure: Change from baseline in the One Back test
timeFrame: Week 12
measure: Change from baseline in the Two Back test
timeFrame: Week 12
measure: Change from baseline in the Groton Maze Learning Test
timeFrame: Week 12
measure: Change from baseline in the Identification Test
timeFrame: Week 12
measure: Change from baseline in the International Shopping List Test
timeFrame: Week 12
measure: Change from baseline on Continuous Paired Associate Learning Test
timeFrame: Week 12
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Aptinyx Clinical Site
state: Arizona
city: Fresno
country: United States
facility: Aptinyx Clinical Site
state: California
city: Simi Valley
country: United States
facility: Aptinyx Clinical Site
state: California
city: Boca Raton
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Bradenton
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Orlando
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Port Charlotte
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Port Orange
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Sunrise
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Decatur
country: United States
facility: Aptinyx Clinical Site
state: Georgia
city: Farmington Hills
country: United States
facility: Aptinyx Clinical Site
state: Michigan
city: Golden Valley
country: United States
facility: Aptinyx Clinical Site
state: Minnesota
city: Toms River
country: United States
facility: Aptinyx Clinical Site
state: New Jersey
city: Poughkeepsie
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Asheville
country: United States
facility: Aptinyx Clinical Site
state: North Carolina
city: Dayton
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Tulsa
country: United States
facility: Aptinyx Clinical Site
state: Oklahoma
city: Round Rock
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Sugar Land
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Bellevue
country: United States
facility: Aptinyx Clinical Site
state: Washington
city: Spokane
country: United States
facility: Aptinyx Clinical Site
state: Washington
Study officials:
References: