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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT04148391
• Date of registration: 30/10/2019
• Prospective Registration: Yes
• Primary sponsor: Aptinyx
• Public title: NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
• Scientific 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
• Date of first enrolment: November 14, 2019
• Target sample size: 99
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04148391
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mild Cognitive Impairment

Parkinson Disease

Lewy Body Disease

Mild Dementia

Intervention(s)

Drug: NYX-458

Drug: Placebo Oral Capsule

Primary Outcome(s)

Change from baseline in physical examination [Time Frame: Subjects will be followed up to 14 days post-dose]

Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results [Time Frame: Subjects will be followed up to 14 days post-dose]

Rates of adverse events and serious adverse events [Time Frame: Subjects will be followed up to 14 days post-dose]

Rates of early termination due to adverse events [Time Frame: 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) [Time Frame: 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) [Time Frame: 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 [Time Frame: Subjects will be followed up to 14 days post-dose]

Change in total score of the Sheehan Suicidality Tracking Scale (S-STS) [Time Frame: Subjects will be followed up to 14 days post-dose]

Secondary Outcome(s)

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 on Continuous Paired Associate Learning Test [Time Frame: Week 12]

Change from baseline in the International Shopping List Test [Time Frame: Week 12]

Secondary ID(s)

NYX-458-2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CogState Ltd.

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