2026 American Academy of Neurology Abstract Website

Objective:

Evaluate interim outcomes from the real-world study of CREXONT, assessing its impact to extend “Good On” time and reduce “Off” time in PD patients after switching from other levodopa-based therapies.

Background:

CREXONT, a novel extended-release carbidopa-levodopa formulation containing a mucoadhesive polymer, is designed to improve levodopa delivery and absorption, enhancing therapeutic benefit. ELEVATE-PD evaluates its safety and efficacy under real-world conditions.

Design/Methods:

ELEVATE-PD is an ongoing multicenter, open-label phase 4 trial. After screening, patients are converted from current therapy (IR CD-LD, IR+COMT inhibitors, or Rytary) to CREXONT and undergo a 5-week dose-optimization period (Visit 1–Day 35), 1-week stable dosing period (Day 35–42) and a 12-month follow-up. Eligible participants have ≥2.5hours daily “Off” time. Primary endpoint is change in daily “Good On” time from baseline (Visit 1) to Day 42/Visit 4, assessed by the PD diary; secondary endpoint is change in daily “Off” time. This interim analysis includes the first 55 patients completing Week 6 (Day 42/Visit 4).

Results:

Fifty-five patients (mean age 66.4±8.95 years) were analyzed. At baseline, mean daily “Good On” time was 9.58±2.36 hours, “Off” time was 5.94±2.02 hours:

- CREXONT treatment increased daily “Good On” time:+3.13 hours for patients switching from IR CD-LD (n=36), +2.31 hours from IR CD-LD+COMT inhibitor (n=6), +1.80 hours from Rytary (n=11).

- Corresponding reductions in “Off” time were –2.82, –2.36, –2.47 hours, respectively.

- CREXONT increased “Good On” time per dose by 1.81, 0.77, 0.78 hours, respectively.

- CREXONT improved MDS-UPDRS total scores by –14.1, –4.2, –10.8 points, respectively.

- TEAEs were mild to moderate; most common (≥3%) were nausea (5.5%), falls (3.6%), dizziness (3.6%), urinary tract infection (3.6%).

Conclusions:

CREXONT substantially increased “Good On” time, reduced “Off” time, and improved motor function in PD patients across all therapy groups, confirming that switching patients from other levodopa-based therapies to CREXONT offers meaningful improvements in symptom control through the day.