Nasal Insulin for Cognitive Impairment

Recruiting in Palo Alto (17 mi)

Overseen bySuzanne Craft

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?The SNIFF Device study will involve using a device to administer insulin through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. This study is measuring how much insulin the device delivers. In addition, this study will look at the effects of insulin or placebo administered intra-nasally using a nebulizer-like device on memory, blood, and cerebral spinal fluid.

Eligibility Criteria

This trial is for individuals with mild cognitive impairment or normal cognition, stable health, and medication use. Participants must have normal lab values or non-significant abnormalities, speak English fluently, and not be pregnant. Excluded are those with regular alcohol/drug use, significant stroke history, any diabetes type, recent insulin/anti-diabetic drugs usage, seizures in the last five years, nursing home residents, investigational drug users within two months prior to screening visit.

Inclusion Criteria

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

Fluent in English

Cognitively normal or diagnosis of aMCI

+2 more

Exclusion Criteria

Residence in a skilled nursing facility at screening

I have diabetes, whether I use insulin or not.

Pregnancy or possible pregnancy.

+9 more

Participant Groups

The study tests a nasal device delivering insulin to see if it affects memory and other cognitive functions. It compares the effects of insulin versus placebo administered through an intranasal nebulizer-like device on participants' memory performance as well as blood and cerebral spinal fluid markers.

2Treatment groups

Experimental Treatment

Group I: Placebo first, then insulinExperimental Treatment3 Interventions

Participants will be randomly assigned to receive placebo administered with an intranasal nebulizer-like device. At visit 3 during second intervention period, participants in this arm will receive insulin.

Group II: Insulin first, then placeboExperimental Treatment3 Interventions

Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive placebo at visit 3 during second intervention period.

Intranasal Insulin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Intranasal insulin for: