SNIFF - Combo INI+EMPA Trial

Prior treatment

• Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
• Use of anticoagulants, unless documentation received from prescribing clinician that anticoagulant medication can be held before lumbar puncture, and approved by study clinician
• Use of an investigational agent within two months of screening visit
• Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case by case basis by the study physician)

Other illness

• A diagnosis of dementia other than Alzheimer's disease (AD)
• History of a clinically significant stroke
• Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
• Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus
• History of seizure within past five years

Other

• Pregnancy or possible pregnancy
• Residence in a skilled nursing facility at screening

• Age 55 to 85 (inclusive)
• Fluent in English
• Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)
• Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria
• Stable medical condition for 3 months prior to screening visit
• Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)
• Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician