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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
MTI Biotech Inc
Study ID
NCT06432166
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 2-hydroxybenzylamine acetate — DRUG
    2-hydroxybenzylamine acetate (2-HOBA) is taken daily for 12 weeks
  • Placebo — OTHER
    Placebo taken three times per day for 12 weeks.

Study Details

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.

Key Dates

First listed
May 29, 2024
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo treatment TID for 12 weeks.
  • Active Comparator: 250 mg 2-HOBA acetate BID
    250 mg of 2-hydroxybenzylamine (2-HOBA) acetate BID for 12 weeks.
  • Active Comparator: 250 mg 2-HOBA acetate TID
    250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 12 weeks.
  • Active Comparator: 500 mg 2-HOBA acetate
    500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 12 weeks.

Primary Outcome Measure

Safety/Tolerability (adverse events) [ Time Frame: Baseline to week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Cognitive Medicine, Vanderbilt University Medical CenterNashvilleTennessee37212
Meagan Adams, MSPM, PMP
[email protected]
(615) 421-4352
Patricia Andrews, M.D. (PRINCIPAL_INVESTIGATOR)
Paul Newhouse, M.D. (SUB_INVESTIGATOR)
Alexander C Conley, Ph.D. (SUB_INVESTIGATOR)

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By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Center for Cognitive Medicine, Vanderbilt University Medical Center· Nashville, TN

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