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SGLT2 Inhibitor

Intranasal Insulin + Empagliflozin for Alzheimer's Disease

Phase 2
Waitlist Available
Led By Suzanne Craft, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 55 to 85 (inclusive)
Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)
Must not have
Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus
History of a clinically significant stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8

Summary

This trial will study the effects of intranasal insulin and the diabetes drug empagliflozin on people with early Alzheimer's disease or mild cognitive impairment.

Who is the study for?
Adults aged 55-85 with preclinical Alzheimer's, amnestic mild cognitive impairment (aMCI), or early Alzheimer's who are fluent in English and have stable medical conditions. Participants must not have a history of significant stroke, diabetes, regular use of certain medications including insulin or anticoagulants, or any major psychiatric disorders.
What is being tested?
The trial is testing the safety and effectiveness of intranasal insulin combined with empagliflozin to improve brain energy and blood vessel function in adults with early signs of Alzheimer's. It involves comparing these treatments against placebo versions using an intranasal device for delivery.
What are the potential side effects?
Possible side effects may include low blood sugar levels due to insulin, urinary tract infections from empagliflozin, nasal irritation from the delivery device, as well as potential allergic reactions to either treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 85 years old.
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I have normal cognition or have been diagnosed with mild memory loss or mild Alzheimer's.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes, whether it requires insulin or not.
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I have had a major stroke in the past.
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I have had a seizure in the last five years.
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I have used insulin or other diabetes medication in the last 2 months.
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I haven't had epilepsy, major head injuries, or severe mental health issues in the last 2 years.
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My diagnosis is a type of dementia that is not Alzheimer's.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Treatment-related Serious Adverse Events as Assessed by CTCAE v5.0
Secondary study objectives
Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181
Change in Cerebrospinal Fluid (CSF) Levels of Total Tau
Change in Total Cerebral Blood Flow (CBF) Using MRI Pseudocontinuous Arterial Spin Labeling (ASL)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Intranasal Insulin and Empagliflozin PlaceboExperimental Treatment3 Interventions
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily * Placebo capsules taken by mouth 30 minutes before breakfast once daily
Group II: Intranasal Insulin and EmpagliflozinExperimental Treatment3 Interventions
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily * Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Group III: Empagliflozin and Intranasal Insulin PlaceboExperimental Treatment3 Interventions
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily * 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Group IV: PlaceboPlacebo Group3 Interventions
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily * Placebo capsules taken by mouth 30 minutes before breakfast once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (Insulin Diluent)
2021
Completed Phase 2
~30
Aptar Pharma CPS Intranasal Delivery Device
2021
Completed Phase 2
~30
Placebo (Capsules)
2021
Completed Phase 2
~30
Insulin (Humulin® R U-100)
2021
Completed Phase 3
~270
Empagliflozin 10 MG
2016
Completed Phase 4
~990

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,451,876 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences / Wake Forest School of Medicine
16 Previous Clinical Trials
1,989 Total Patients Enrolled

Media Library

Empagliflozin 10 MG (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05081219 — Phase 2
Alzheimer's Disease Research Study Groups: Intranasal Insulin and Empagliflozin Placebo, Empagliflozin and Intranasal Insulin Placebo, Intranasal Insulin and Empagliflozin, Placebo
Alzheimer's Disease Clinical Trial 2023: Empagliflozin 10 MG Highlights & Side Effects. Trial Name: NCT05081219 — Phase 2
Empagliflozin 10 MG (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081219 — Phase 2
~7 spots leftby Nov 2025