Table 1.

Selection criteria for the patients

Inclusion criteria. Each patient met the following criteria:  • Subjects who are able and willing to provide informed consent.  • Male and non-pregnant, non-lactating, postmenopausal, or surgically sterilized female subjects at least 60 years of age or older.  • Clinical diagnosis of amnestic MCI by the Peterson criteria or probable AD dementia according to the National Institute of Neurological Disorders and stroke and the Alzheimer’s Disease related Disorders Association (NINCDS/ADRDA).  • MMSE score >21, CDR score >0.5 and <1 Cornell Scale for Depression in Dementia (CSDD) score <10.  • Ambulatory or ambulatory with aide.  • Has a caregiver willing to accompany the patient to each visit, accept responsibility for supervising treatment and provided input to clinical outcome assessments.  • Reside at home.  • Speak English.  • Amyloid positive PET-scan.  • Patients taking FDA approved medications for the treatment of Alzheimer’s disease [e.g., donepezil (Aricept), galantamine (Razadyne), rivastigmine (Exelon), or memantine (Namenda)] for three months prior to baseline. Patients not on these medications did not initiate them during the study. Exclusion criteria  • Significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury.  • A current psychiatric disorder according the DSM-IV diagnosis of major depression unless successfully treated on a stable dose of an antidepressant for at least 4 weeks and continues on stable dose throughout the study.  • Any other DSM-IV Axis l diagnosis including other primary neurodegenerative dementia, schizophrenia or bipolar depression.  • A current diagnosis of uncontrolled Type I or Type II diabetes mellitus [Hemoglobin A1 C (Hb A1C<8]. Patients with uncontrolled diabetes (i.e., if glucose values exceed 200 mg/ml.  • A current diagnosis of active, uncontrolled seizure disorder.  • A current diagnosis of probable or possible vascular dementia according to NINDS-AIREN.  • An investigational drug during the previous 4 weeks.  • Any previous exposure to Benfotiamine.  • A current diagnosis of severe unstable cardiovascular disease.  • A current diagnosis of acute severe, or unstable asthmatic condition (e.g., severe chronic obstructive pulmonary disease).  • A current diagnosis of cardiac, renal or hepatic disease.  • A current diagnosis of cancer including any active treatment.  • History of alcoholism, current or within past 5 years.  • A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty).