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Anti-glycation Agent

2-HOBA for Alzheimer's Disease (2-HOBA Trial)

Phase 1 & 2
Waitlist Available
Led By Paul Newhouse, M.D.
Research Sponsored by MTI Biotech Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is not pregnant, lactating, or of childbearing potential
Age 55-85
Must not have
Clinically significant or unstable medical condition
Any other significant neurologic disease including Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 16
Awards & highlights

Summary

This trial will test the safety and effectiveness of a medication called 2-HOBA in 48 participants with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD). Participants will

Who is the study for?
This trial is for individuals with early Alzheimer's or mild cognitive impairment. Participants will be chosen to ensure they are in the early stages of these conditions and can safely undergo treatment and testing, which includes blood draws and spinal taps.
What is being tested?
The study tests different doses of a compound called 2-HOBA acetate (250, 500, or 750 mg) taken three times daily against a placebo to see if it's safe and affects certain biomarkers related to Alzheimer's disease over a period of 16 weeks.
What are the potential side effects?
As this is an early-stage trial for safety and tolerability, specific side effects are not listed but may include reactions at the site of blood draw or spinal tap, gastrointestinal discomfort, headaches, or other unforeseen responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, breastfeeding, or able to become pregnant.
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I am between 55 and 85 years old.
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I am between 55 and 85 years old with mild cognitive impairment due to Alzheimer's.
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My test shows I have amyloid proteins in my blood.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious or unstable health conditions.
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I do not have significant neurological conditions like Parkinson's or MS.
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I have not had cancer in the last 5 years.
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I have not been diagnosed with major depression, bipolar disorder, or had psychotic episodes in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in dicarbonyl protein adducts
Safety/Tolerability (adverse events)
Secondary study objectives
Compliance
Measurement biomarker, human cartilage glycoprotein 39 (YKL-4)
Measurement of biomarker, 8-hydroxy-2'-deoxyguanosine
+3 more
Other study objectives
Activities of Daily Living (ADL)
Quantitative Electroencephalography (EEG)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: 250 mg 2-HOBA acetateActive Control1 Intervention
250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
Group II: 500 mg 2-HOBA acetateActive Control1 Intervention
500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
Group III: 750 mg 2-HOBA acetateActive Control1 Intervention
750 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo treatment TID for 16 weeks.

Find a Location

Who is running the clinical trial?

MTI Biotech IncLead Sponsor
Vanderbilt University Medical CenterOTHER
888 Previous Clinical Trials
934,886 Total Patients Enrolled
Paul Newhouse, M.D.Principal InvestigatorVanderbilt University Medical Center
~32 spots leftby Jun 2027
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