CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Insulin +2 moredrug
Likely dose
Insulin 20 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03857321
NCT03857321Phase 2Completed
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Device Study for Intranasal Delivery of Insulin

Wake Forest University Health Sciences·interventional·Posted Feb 27, 2019·Updated Oct 31, 2025

In Brief

A Phase 2 clinical trial evaluating Insulin, Placebo, and 1 other intervention for Mild Cognitive Impairment and Cognitive Impairment. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment, Cognitive Impairment
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 27, 2019
Enrollment StartApr 12, 2019
Primary CompletionSep 27, 2019
Study CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago

Interventions

Insulindrug

20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company)

Placeboother

Matching placebo (sterile saline) to 20 IU Humulin® R U-100

intranasal nebulizer-like devicedevice

Participants will be assigned to receive placebo or regular insulin (U100, 20 IU) administered through an intranasal nebulizer-like device.