Wake Forest University Health Sciences
The purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.
The proposed pilot study will evaluate the efficacy, safety and tolerability of two therapeutic approaches: treatment with intranasal insulin in combination with anti-amyloid targeting therapy (ATT) and treatment with the sodium-glucose cotransporter type 2 inhibitor empagliflozin in combination with ATT, to correct bioenergetic and vascular dysfunction in adults with mild cognitive impairment due to Alzheimer's disease or mild dementia due to Alzheimer's disease.
Inclusion Criteria: * Fluent in English * Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment * Amyloid positive by PET or cerebrospinal fluid criteria * Stable medical condition for 3 months prior to screening visit * Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician) * Stable on Anti-Amyloid Targeting Therapy (lecanemab or donanemab) for at least 8 weeks prior to Baseline Visit * If rece…
empagliflozin 10 mg every day
Intranasal insulin 40 international units four times daily
matching placebo for intranasal insulin
matching placebo for empagliflozin
Arctuva estimate
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