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COMPLETED
NCT05081219
PHASE2

SNIFF - Combo INI+EMPA Trial

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

DRUG

Insulin (Humulin® R U-100)

Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.

DRUG

Empagliflozin 10 MG

Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.

DEVICE

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.

DRUG

Placebo (Insulin Diluent)

Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.

DRUG

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