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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

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