NCT04199767

SNIFF Multi-Device Study 2

SNIFF Multi-Device Study 2 - Study of Nasal Insulin to Fight Forgetfulness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF). A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels. The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI 20 International Units or 40 International Units delivered with one of three nebulizer-like devices on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either 20 or 40 IU insulin first, and the opposite dose on a second visit. Participants who are cognitively normal or who have aMCI (n=30) will be enrolled. The primary outcome measure will be to establish which device and which dose provides the greatest increase in CSF insulin which will provide important evidence to be used in the design of future trials.

Conditions

• Mild Cognitive Impairment
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)	Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
DRUG	40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)	Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.

Timeline

• Start date: 2020-07-16
• Primary completion: 2020-11-03
• Completion: 2020-11-03
• First posted: 2019-12-16
• Last updated: 2026-04-02
• Results posted: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study