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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 7, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT05081219). This is a study registration, not published results. Lead sponsor: Wake Forest University Health Sciences. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 47 participants (ACTUAL). Conditions: Mild Cognitive Impairment, Cognitive Impairment, Alzheimer Disease. Interventions: DRUG: Insulin (Humulin® R U-100); DRUG: Empagliflozin 10 MG; DEVICE: Aptar Pharma CPS Intranasal Delivery Device; DRUG: Placebo (Insulin Diluent); DRUG: Placebo (Capsules). Primary outcome measures: Number of Participants With Treatment-Related Serious Adverse Events as Assessed by CTCAE v5.0 , Week 8. Brief summary: The proposed pilot study will provide safety and efficacy preliminary data regarding singular and combined effects of two therapeutic approaches, intranasal insulin and treatment with the sodium-glucose cotransporter type 2 inhibitor (SGLT2i) empagliflozin, to correct bioenergetic and vascular dysfunction in adults with preclinical Alzheimer's disease (AD) and amnestic mild cognitive impairment (aMCI) or early AD.