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SGLT2 Inhibitor

Intranasal Insulin + Empagliflozin for Alzheimer's Disease

Phase 2

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Treatment-related Serious Adverse Events as Assessed by CTCAE v5.0

Secondary outcome measures

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

Insulin (Humulin® R U-100)

2014

Completed Phase 3

~240

Empagliflozin 10 MG

2016

Completed Phase 4

~900

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,666 Total Patients Enrolled

Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences / Wake Forest School of Medicine

16 Previous Clinical Trials

2,007 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the usual purpose of administration for Insulin (Humulin® R U-100)?

"Humulin® R U-100 has been found to be a viable mode of treatment for conditions such as exercise-induced fatigue, hospital acquired pneumonia and type 1 diabetes mellitus."

Answered by AI

Are applicants of 45 years or older being considered for this clinical experiment?

"This clinical study is open to individuals aged 55-85. There are 65 studies for minors and 1074 opportunities for elderly participants."

Answered by AI

How many individuals are being recruited for participation in this trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively engaging participants since its initial post date on October 14th 2021 and latest update of the 28th 2022. Sixty patients need to be enlisted from one single site for successful completion of the study."

Answered by AI

Is it currently possible to join this clinical experiment?

"Affirmative. Clinicaltrials.gov evidence proves that this trial is recruiting patients; it was posted on October 14th 2021 and the listing most recently updated on October 28th 2022. The study necessitates 60 participants from 1 medical centre."

Answered by AI

Are there any restrictions on who may participate in this medical experiment?

"This investigation requires 60 volunteers who suffer from Alzheimer's disease and are within the ages 55 to 85. Specific eligibility criteria for applicants include being cognitively normal or having mild aMCI/AD, possessing medically stable conditions 3 months prior to screening, and maintaining consistent medication in the 4 weeks leading up to study visits (modifications may be made at the discretion of physicians)."

Answered by AI

Has the United States Food and Drug Administration approved Humulin® R U-100 Insulin?

"A score of 2 was assigned to Humulin® R U-100 in terms of safety since there is only a limited amount of clinical data available about its efficacy."

Answered by AI

Could you provide information on any former trials conducted with Insulin (Humulin® R U-100)?

"Currently, 135 studies are underway for Insulin (Humulin® R U-100) with 32 of them in the final Phase 3. While Quilmes, Maryland is home to most trials for this drug, it can be found at 1370 distinct sites throughout the world."

Answered by AI