Study of Nasal Insulin to Fight Forgetfulness - Device Study

December 12, 2023 updated by: Wake Forest University Health Sciences

Device Study for Intranasal Delivery of Insulin

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 placebo delivered with nebulizer-like device on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either an acute dose of insulin or placebo first, and the other substance 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 test the hypothesis that CSF insulin levels will increase 30 minutes after receiving a 20 International Units dose of insulin delivered with a nebulizer-like device, compared to levels achieved 30 minutes after placebo.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 cancer five years prior to screening (history of skin melanoma or stable prostate cancer are not exclusionary)
  • 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
  • Regular use of alcohol, narcotics, anticonvulsants, antiparkinsonian medications, or any other exclusionary medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin first, then placebo
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
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Other Names:
  • Humulin® R U-100
Other: Placebo
Matching placebo (sterile saline) to 20 IU Humulin® R U-100
Other Names:
  • Sterile saline
  • placebo to Humulin® R U-100
Device: intranasal nebulizer-like device
Participants will be assigned to receive placebo or regular insulin (U100, 20 IU) administered through an intranasal nebulizer-like device.
Experimental: Placebo first, then insulin
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
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Other Names:
  • Humulin® R U-100
Other: Placebo
Matching placebo (sterile saline) to 20 IU Humulin® R U-100
Other Names:
  • Sterile saline
  • placebo to Humulin® R U-100
Device: intranasal nebulizer-like device
Participants will be assigned to receive placebo or regular insulin (U100, 20 IU) administered through an intranasal nebulizer-like device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF insulin levels
Time Frame: 30 minutes after intervention administration
Levels of insulin in CS 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF Levels of AB42
Time Frame: 30 minutes after intervention administration
Levels of the 42 amino acid isoform of the beta amyloid peptide
30 minutes after intervention administration
The Auditory-Verbal Learning Test (AVLT)
Time Frame: 5 minutes before lumbar puncture, and immediately following lumbar puncture
memory measure in which participant hears a list of 12 words over 3 trials, and is asked to recall them immediately after hearing them, then again after a 45 minute delay. Total possible score is 36 for immediate recall and 12 for delayed recall. Higher scores are better.
5 minutes before lumbar puncture, and immediately following lumbar puncture
CSF Levels of total tau
Time Frame: 30 minutes after intervention administration
Levels of the tau protein
30 minutes after intervention administration
CSF Levels phospho-tau 181
Time Frame: 30 minutes after intervention administration
Levels of the tau phosphorylated at isotope 181
30 minutes after intervention administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Suzanne Craft, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00055429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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