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2-Hydroxybenzylamine (2-HOBA) Study for Early Alzheimer's

This study is testing a drug called 2-hydroxybenzylamine acetate (2-HOBA) for people with early Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's. The main goals are to see if 2-HOBA is safe and well-tolerated, and if it can reduce certain protein changes in the brain that are linked to Alzheimer's. You would take either 2-HOBA or a placebo (an inactive substance) three times a day for 16 weeks. Researchers will collect blood and spinal fluid to measure markers related to Alzheimer's. The study aims to enroll 48 participants aged 55 to 85 who have memory concerns and specific scores on cognitive tests. The current status of the study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the drug or a placebo, and neither you nor the researchers will know which you are receiving. It is a phase 1b/2a study, aiming for 48 participants.
What's involved
You would take the study drug or placebo three times a day for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure various markers.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured from baseline to week 16, and changes in protein adducts will also be measured during this 16-week period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06432166

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

Not Yet Recruiting
PHASE1Ages 55–85InterventionalTreatment
MTI Biotech Inc
~48 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:2-hydroxybenzylamine acetatePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety/Tolerability (adverse events)
Measured over Baseline to week 12
+1 more outcome measured

Conditions

Alzheimer Disease
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseMild cognitive disorderAmyloid

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Patricia Andrews, M.D. · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
  • John A. Rathmacher, Ph.D. · PRINCIPAL_INVESTIGATOR · MTI Biotech Inc

Who to contact

John A. Rathmacher, Ph.D.
[email protected]
515-296-9916
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Less than or equal to 11 for 16 or more years of education
Less than or equal to 9 for 8 - 15 years of education
Less than or equal to 6 for 0 - 7 years of education 3. Amyloid positivity established using the C2N Precivity2 Plasma test (Aβ42/40 plus p tau217/np-tau217. (This test uses a statistical algorithm to integrate a patient's Aβ42/40 Ratio and p-Tau217 Ratio to calculate the Amyloid Probability Score 2 (APS2) and determines whether a patient is positive or negative for brain amyloid deposition based on a binary cutoff value). 4. Stable permitted medications for 4 weeks or longer as specified in Section 4.6.3, including:

Exclusion

Use centrally acting anti-cholinergic drugs.
Use of any investigational drugs within 4 weeks or 5 half-lives, whichever is longer, prior to screening. 11. A current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening. 12. Contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker. 13. Participants whom the Site PI deems to be otherwise ineligible. 14. Current use of monoamine oxidase inhibitors (MAOIs) or use within 14 days (or 5 half-lives, whichever is longer) prior to screening, This includes non-selective MAOIs (phenelzine, tranylcypromine, isocarboxazid), MAO-B inhibitors (selegiline, rasagiline, safinamide), reversible MAO-A inhibitors (moclobemide), and other agents with MAOI A inhibitory activity (linezolid, methylene blue at doses \>1 mg/kg). This exclusion is required because 2-HOBA has demonstrated MAO-A inhibitory activity in vitro.

What this trial measures

  • Safety/Tolerability (adverse events)Baseline to week 12

    Rates of adverse events will be compared between active and placebo arms and presented as summary statistics.

  • Change in dicarbonyl protein adductsBaseline to week 12

    Change in CSF levels of the dilysyl-malondialdehyde crosslink and the lysyl-levuglandin adduct of CSF proteins in a dose-responsive relationship