Study of Nasal Insulin to Fight Forgetfulness - Device Study

NCT03857321 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: IRB00055429
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Cognitive Impairment

Keywords

Intranasal Delivery of Insulin; Cognitive Testing; Nasal Insulin

Outcome Measures

Primary Outcomes (1)

• CSF Insulin Levels

  Levels of insulin in cerebrospinal fluid after being delivered with the device. This will help to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF)

  30 minutes after intervention administration

Secondary Outcomes (4)

• The Auditory-Verbal Learning Test (AVLT)

  5 minutes before lumbar puncture, and immediately following lumbar puncture

• CSF Levels of AB42

  30 minutes after intervention administration

• CSF Levels of Total Tau

  30 minutes after intervention administration

• CSF Levels Phospho-tau 181

  30 minutes after intervention administration

Study Arms (2)

Insulin first, then placebo

EXPERIMENTAL

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.

Drug: Insulin; Other: Placebo; Device: intranasal nebulizer-like device

Placebo first, then insulin

EXPERIMENTAL

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.

Drug: Insulin; Other: Placebo; Device: intranasal nebulizer-like device

Interventions

Insulin DRUG

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

Also known as: Humulin® R U-100

Insulin first, then placebo; Placebo first, then insulin

Placebo OTHER

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

Also known as: placebo to Humulin® R U-100, Sterile saline

Insulin first, then placebo; Placebo first, then insulin

intranasal nebulizer-like device DEVICE

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

Insulin first, then placebo; Placebo first, then insulin

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English
• Cognitively normal or diagnosis of aMCI
• Stable medical condition for 3 months prior to screening visit
• Stable medications for 4 weeks prior to the screening and study visits
• Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

You may not qualify if:

• A diagnosis of dementia
• History of a clinically significant stroke
• Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
• Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
• Current or past use of insulin or any other anti-diabetic medication within 5 years of Screening visit.
• History of seizure within past five years
• Pregnancy or possible pregnancy.
• Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa)
• Residence in a skilled nursing facility at screening
• Use of an investigational agent within two months of screening visit

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

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MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Insulin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Suzanne Craft, PhD
• Organization: Atrium Health Wake Forest

suzcraft@wakehealth.edu

336-713-8846

Study Officials

• Suzanne Craft, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants or site personnel will know whether insulin or saline is being administered. Exceptions will be the study nurse who is directly involved in preparing the insulin or placebo, as well as preparing DSMB reports.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At study entry, participants will be randomized to receive either an acute dose of insulin or of placebo first and the other substance on a second visit.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 27, 2019
• Study Start: April 12, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 30, 2019
• Last Updated: October 31, 2025
• Results First Posted: August 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)