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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aptinyx
• Collaborators: CogState Ltd.; Worldwide Clinical Trials

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.