NCT04148391 · Phase 2 · ACTIVE NOT RECRUITING
NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
This trial is testing NYX-458, an experimental oral drug, against a placebo in people who have mild cognitive impairment or mild dementia caused by Parkinson's disease or Lewy body dementia. Researchers are measuring whether it improves cognition, memory, attention, and thinking. This is a Phase 2 trial, meaning scientists are still trying to determine whether it works and whether it is safe — it is not proven or approved.
You may qualify if
- 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
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-10-27