Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Aptinyx
Enrollment:
135
Study Design:
This is a phase 2, randomized, parallel-group, triple blinded study evaluating the safety and tolerability of NYX-458 in MCI associated with PD. Participants between 50-80 years of age with a primary diagnosis of MCI associated with PD will be eligible for inclusion. They should be on a stable antiparkinsonian medication regimen. Participants with MoCA <17 and those meeting criteria for dementia will be excluded. The exclusion criteria also include an ambiguous point of excluding those on medication with primarily central nervous system activities. The study will be conducted over 16-18 weeks which will include the following, in sequential order: 1. Screening: 2 to 4-weeks; 2. Intervention: 12-weeks; and 3. Follow up: 2-weeks. The trial is studying the safety profile of 3 dosing regimens of the investigation drug. The participants will be randomized to one of the following four arms: 1. Experimental: where participants will receive a 10mg daily dose for 12 weeks; 2. Experimental: where participants will receive a 30mg daily dose for 12 weeks; 3. Experimental: where participants will receive 100mg daily dose for 12 weeks; and 4. Placebo. The study is being conducted at multiple sites across the USA.
Rationale:
The primary outcome measure focuses on safety by assessing the number of participants with adverse events. Secondary outcomes aim to measure efficacy across multiple cognitive scales though not well outlined in the clinicaltrials.gov.
Comments:
NMDAR is an interesting potential target, and NYX-458 is a promising molecule based on preclinical studies. The current clinical trial, as expected and rightly so, is focusing on the safety and tolerability of 3 doses of NYX-458. Whether preclinical benefits will translate into clinically meaningful effect is yet to be determined with further studies, contingent upon Phase 2 safety results.
