MTI Biotech Inc
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.
This is 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 CSF will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L. Investigators anticipate screening 120 subjects to randomize up to 60 subjects with the goal of 48 patients completing the stud…
Inclusion Criteria: MCI due to AD: 1. Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. 2. Participant must have a subjective memory concern as reported by participant, study partner, or clinician. 3. Mini-Mental State Exam31 score between 24 and 30, inclusive 4. Clinical Dementia Rating (CDR)32 Global = 0.5. Memory Box score must be at least 0.5 Mild AD: 1. Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. 2. MCI or Mild dementia of the Alzheimer's type according to the NIA-AA 2018 criteria. 3. CDR global sc…
2-hydroxybenzylamine acetate (2-HOBA) is taken daily for 12 weeks
Placebo taken three times per day for 12 weeks.
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