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SNIFF - Combo INI+EMPA Trial
Sponsor: Wake Forest University Health Sciences
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.
Official title: Study of Nasal Insulin to Fight Forgetfulness - Combination Intranasal Insulin and Empagliflozin Trial
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2021-09-14
Completion Date
2024-09-17
Last Updated
2026-10-07
Healthy Volunteers
Yes
Interventions
Insulin (Humulin® R U-100)
Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG
Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device
Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent)
Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules)
Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
Locations (1)
Wake Forest University Health Sciences / Wake Forest School of Medicine
Winston-Salem, North Carolina, United States