drugset / Trial / NCT06432166
2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients
Phase 1/2
Not yet recruiting
48 enrolled
MTI Biotech Inc
Vanderbilt University Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2028-06-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 2-(AMINOMETHYL)PHENOL | Small molecule | 250 mg | — |
| Comparator | 2-(AMINOMETHYL)PHENOL | Small molecule | 500 mg | — |
| Comparator | 2-(AMINOMETHYL)PHENOL | Small molecule | 750 mg | — |