Vegetative State clinical trials at UCLA

The study will evaluate the safety and preliminary efficacy of saxagliptin in treating prolonged DoC through a randomized, placebo-controlled, double-blind, delayed start Phase IIA trial. Twenty-four (24) patients with prolonged DOC (≥28 days post-injury) will be enrolled at Rehabilitation Hopsital's Center for Disorders of Consciousness (C³DoC). Twelve patients will be randomized to receive placebo for 15 days followed by saxagliptin 5 mg for 15 days (Delayed Start Group), and 12 will receive saxagliptin 5 mg for the full 30 days (Full Treatment Group). Patients will be under continuous medical monitoring within C³DoC throughout their approximately 4-week admission. Validated behavioral biomarkers of consciousness (CRS-R) will be collected by blinded certified assessors at baseline (days -7 and 0), day 15, and day 30, with portable EEG-based AI biomarker assessments to corroborate behavioral findings. Follow-up DRS-PI assessments will be conducted at days 60 and 90. A pre-planned adaptive dose escalation design will be employed. The first 6 patients (sentinel cohort) will receive 5 mg (or placebo per delayed start). Upon cohort completion, the independent Safety Monitoring Board (SMB), chaired by a Medical doctor , will review unblinded safety data. If IRB and FDA IND Exemption approval is obtained for dose escalation, and excellent safety criteria are met (zero SAEs, no Grade 2+ AEs, zero hypoglycemia), the SMB will direct escalation to 10 mg for subsequent patients (up to 400 mg/day has been shown to be well-tolerated in humans); otherwise, 5 mg continues. Investigators and patients remain blinded throughout.