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SNIFF - Combo INI+EMPA Trial

NCT05081219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-10-21

Study results available
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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.

Conditions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Suzanne Craft, PhD · Wake Forest University Health Sciences / Wake Forest School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2024-09-17
Completion
2024-09-17
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081219 on ClinicalTrials.gov