Intranasal Insulin + Empagliflozin for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

Overseen bySuzanne Craft, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

My health condition has been stable for the last 3 months.

My medications have been the same for the last 4 weeks.

Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

See 4 more

Exclusion Criteria

I have diabetes, whether it requires insulin or not.

My doctor agrees I can stop my blood thinner before a lumbar puncture, if needed for the study.

Pregnancy or possible pregnancy

See 8 more

Treatment Details

Interventions

Empagliflozin 10 MG (SGLT2 Inhibitor)
Insulin (Humulin® R U-100) (Insulin)

Trial OverviewThe 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.

Participant Groups

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

Empagliflozin 10 MG is already approved in United States, European Union, Australia for the following indications:

🇺🇸 Approved in United States as Jardiance for: