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

NCT06432166 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

2-hydroxybenzylamine acetate

2-hydroxybenzylamine acetate (2-HOBA) is taken three times per day for 16 weeks

OTHER

Placebo

Placebo taken three times per day for 16 weeks.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • MTI Biotech Inc

    lead INDUSTRY

Principal Investigators

  • Paul Newhouse, M.D. · Vanderbilt University Medical Center

  • John A. Rathmacher, Ph.D. · MTI Biotech Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432166 on ClinicalTrials.gov