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SNIFF Multi-Device Study 2

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04199767
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
38.5
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
  • Drug: 40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
At study entry, participants will be randomized to receive either 20 or 40 International Units of insulin first and the opposite substance on a second visit.At study entry, participants will be randomized to receive either 20 or 40 International Units of insulin first and the opposite substance on a second visit.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Neither participants or site personnel will know which dose of insulin is being administered. Exceptions will be the study nurse who is directly involved in preparing the insulin.
Primary Purpose:
Treatment
Official Title:
SNIFF Multi-Device Study 2 - Study of Nasal Insulin to Fight Forgetfulness
Actual Study Start Date :
Jul 16, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 20 IU Insulin first, then 40 IU Insulin

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.

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.
Other Names:
  • Humulin® R U-100

    		•
    Experimental: 40 IU Insulin first, then 20 IU Insulin

    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.

    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.
    Other Names:
  • Humulin® R U-100

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CSF insulin levels [30 minutes after intervention administration]

      To compare changes in CSF insulin levels after receiving a 20 or 40 International Unit dose of insulin delivered with one of three devices, compared to baseline levels.

    Secondary Outcome Measures

    1. Auditory-Verbal Learning Test (AVLT) [5 minutes before lumbar puncture, and immediately following lumbar puncture.]

      To examine differences in memory performance measured with a list learning test (Auditory Verbal Learning Test) after administration of 20 or 40 IU insulin.

    Other Outcome Measures

    1. CSF Levels of AB42 [30 minutes after intervention administration]

      Levels of the 42 amino acid isoform of the beta amyloid peptide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 regular use of insulin or any other anti-diabetic medication within 2 months 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

    • Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04199767
    Other Study ID Numbers:
    • IRB00062612
    First Posted:
    Dec 16, 2019
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wake Forest University Health Sciences
    Intranasal Delivery of Insulin
    Cognitive Testing
    Nasal Insulin
    Additional relevant MeSH terms:
    Cognitive Dysfunction
    Insulin
    Insulin, Globin Zinc
    Insulin, Isophane

    Study Results

    No Results Posted as of Nov 4, 2021