CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Insulin (Humulin® R U-100) +4 moredrug
Likely dose
Empagliflozin 10 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05081219
NCT05081219Phase 2Completed
CompareCT.gov

Study of Nasal Insulin to Fight Forgetfulness - Combination Intranasal Insulin and Empagliflozin Trial

Wake Forest University Health Sciences·interventional·Posted Oct 18, 2021·Updated Oct 21, 2025

In Brief

A Phase 2 clinical trial evaluating Insulin (Humulin® R U-100), Empagliflozin 10 MG, and 3 other interventions for Mild Cognitive Impairment and 2 related conditions. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment, Cognitive Impairment, Alzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 18, 2021
Enrollment StartSep 14, 2021
Primary CompletionSep 17, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.7 years ago

Interventions

Insulin (Humulin® R U-100)drug

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

Empagliflozin 10 MGdrug

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

Aptar Pharma CPS Intranasal Delivery Devicedevice

Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.

Placebo (Insulin Diluent)drug

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

Placebo (Capsules)drug

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