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. 2024 May 29;19(5):e0302998. doi: 10.1371/journal.pone.0302998

Table 2. Exclusion criteria.

Exclusion Criteria
1. Significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury.
2. Diagnosis of uncontrolled depression or major depression, as determined by DSM-IV, unless successfully treated.
3. Any other major psychiatric disorder that impairs cognition or impacts participation in the study is exclusionary. Participants with major psychiatric disorders (e.g., severe generalized anxiety disorder, bipolar disorder, schizophrenia etc.) where the condition is felt to be the most significant contributor to the cognitive impairment should be excluded.
4. Active medical conditions that impair cognition or impact participation in the study, other than AD should be exclusionary. Participants with medical conditions (e.g., severe obstructive sleep apnea) in whom the condition is felt to be the most significant contributor to the cognitive impairment should be excluded.
5. Significant neurodegenerative diseases, other than AD, and other causes of dementias.
6. A current diagnosis of uncontrolled type I or type II diabetes mellitus, as defined by Hemoglobin A1 C (Hb A1C > 8).
7. A current active, uncontrolled seizure disorder.
8. Participation in another clinical trial for an investigational agent of:
  1. Symptomatic medications, participation is excluded within 4 weeks prior to the screening visit.

  2. Disease-modifying medications, participation is excluded within 6 months of the screening visit.

9. Previous exposure to benfotiamine within past 3 months.
10. Current serious or unstable medical illness that could interfere with the interpretation of safety and assessment of efficacy in this study.
11. Diagnosis or treatment of cancer within the past 5 years.
12. History of alcoholism or substance abuse, current or within past 5 years.
13. Contraindication to MRI.
14. MRI at screening showing evidence of infection, tumor, cortical infarction, or multiple lacunes in prefrontal or critical memory regions.
15. Initiation of an FDA-approved monoclonal antibody treatment targeting brain amyloid (including lecanemab, aducanumab, solanezumab, donanemab) within 6 months prior to the screening visit.
16. A disability that may prevent the patient from completing all study requirements in the opinion of the PI.