Fig 1.
Schedule of enrollment, interventions, and assessments.
Abbreviations: ECG, electrocardiogram; TSH, thyroid stimulating hormone; PK, pharmacokinetic; PD, pharmacodynamic; AGE, advanced glycation end products; ThDP, thiamine diphosphate; ThMP, thiamine monophosphate; Nfl, neurofilament light chain; GFAP, glial fibrillary acidic protein; Aβ, beta-amyloid; MRI, magnetic resonance imaging; CSF, cerebrospinal fluid; LP, lumbar puncture; CAGE-AID, CAGE Adapted to Include Drugs; C-SSRS, Columbia Suicide Severity Rating Scale; MoCA, Montreal Cognitive Assessment; MMSE, Mini-Mental State Examination; CDR, Clinical Dementia Rating; ADAS-Cog13, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13; ADCS-ADL-MCI, Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for use in Mild Cognitive Impairment; NPI, Neuropsychiatric Inventory; IP, investigational product.
Fig 2.
Abbreviations: BF, benfotiamine; OD, every day; DSMB, Data Safety Monitoring Board.
Table 1.
Inclusion criteria.
Table 2.
Exclusion criteria.
Table 3.
Sample sizes which achieve 90% power for given effect sizes (Cohen’s D; difference between the 2 arms), assuming 20% dropout and assuming drop-in rates of 5% and 10%.