SNIFF Multi-Device Study 2

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04199767
• Other study ID #: IRB00062612
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 16, 2020
• Est. completion date: October 2026

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CSF Levels of AB42	Levels of the 42 amino acid isoform of the beta amyloid peptide	30 minutes after intervention administration
Primary	CSF insulin levels	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.	30 minutes after intervention administration
Secondary	Auditory-Verbal Learning Test (AVLT)	To examine differences in memory performance measured with a list learning test (Auditory Verbal Learning Test) after administration of 20 or 40 IU insulin.	5 minutes before lumbar puncture, and immediately following lumbar puncture.