NeuroSense’s PrimeC Shows Biomarker Shifts in Tau, Aβ and TDP-43 in Phase 2 Study
NRSN•PrimeC treatment in an 8-patient Phase 2 RoAD study produced directional changes in CSF and plasma biomarkers including total tau, phospho-tau(s), Aβ42/40 ratio, alpha-synuclein species and TDP-43, indicating engagement of multiple neurodegeneration pathways. No serious adverse events or new safety signals were reported.
1. Proof-of-Concept Study Design
The RoAD study (NST-AD-001) was a Phase 2, randomized, double-blind, placebo-controlled proof-of-concept trial evaluating PrimeC in eight Alzheimer’s patients. Three participants completed a 12-month follow-up with CSF and plasma sampled at baseline, mid-point and endpoint.
2. Biomarker Findings
Analysis revealed directional changes in key Alzheimer’s markers: total tau, phospho-tau(s) and the amyloid-beta 42/40 ratio, along with alterations in alpha-synuclein species (total, oligomeric, p129) and both total and p409 TDP-43. Additional shifts were seen in oxidative stress and inflammation biomarkers, aligning with PrimeC’s proposed multi-target mechanism.
3. Safety and Tolerability
PrimeC demonstrated a favorable safety profile with no serious adverse events or unexpected safety signals identified during the 12-month study. These findings reinforce previously observed tolerability in the company’s ALS program.
4. Next Steps
NeuroSense plans to leverage these biomarker results to design a larger, adequately powered Alzheimer’s trial. Engagement with scientific and regulatory stakeholders will guide endpoint selection and study size to test clinical benefits.
