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NCT06432166 · ClinicalTrials.gov record · last posted 2026-08-24

2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients

Study acronym: 2-HOBA
StatusNot Yet Recruiting
PhasePhase 1/2
Started2026-09-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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 mg BID, 250 and 500 mg 2-HOBA acetate TID or placebo for 12 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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-25
Primary completion pushed: 2028-06-30 → 2028-12-30
2026-08-25
Completion pushed: 2028-12-31 → 2029-06-30
Trial Details
NCT Number NCT06432166
Lead Sponsor MTI Biotech Inc
Collaborators: Vanderbilt University Medical Center
Conditions Alzheimer Disease, Mild Cognitive Impairment
Enrollment 48 participants
Start Date 2026-09-01
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-24