Nasal Insulin for Alzheimer's

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The SNIFF Device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. This goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (CSF). In addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.

Eligibility Criteria

This trial is for adults with mild cognitive impairment or normal cognition, stable health, and no major psychiatric disorders. They must not be using certain anticoagulants, insulin, or have a history of significant neurological issues like seizures or stroke. Pregnant individuals and those in nursing facilities can't participate.

Inclusion Criteria

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

Cognitively normal or diagnosis of aMCI

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

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Exclusion Criteria

You have taken a new and experimental drug within two months before the screening visit.

I have had a seizure in the last five years.

I have diabetes, whether I use insulin or not.

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Treatment Details

Interventions

SNIFF Device (Other)

Trial OverviewThe study tests how well three different devices deliver insulin to the brain's cerebrospinal fluid when administered through the nose. It also examines the effects on memory and blood insulin levels.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: 40 IU Insulin first, then 20 IU InsulinExperimental Treatment1 Intervention

Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.

Group II: 20 IU Insulin first, then 40 IU InsulinExperimental Treatment1 Intervention

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 regular insulin (U100, 40 IU) at visit 3 during second intervention period.