SNIFF Multi-Device Study 2

Phase 2CompletedNCT04199767

Wake Forest University Health Sciences13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Mild Cognitive Impairment Cognitive Impairment

Interventions

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

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)DRUG

Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Cerebrospinal Fluid Insulin Levels

Change in cerebrospinal fluid insulin levels after receiving a 20 or 40 International Unit dose of insulin delivered with one of three devices

Time frame: Baseline to 30 minutes after intervention administration

Secondary Outcomes

Auditory-Verbal Learning Test

Memory performance measured with Auditory Verbal Learning Test after administration of 20 or 40 IU insulin. Memory measure in which participant hears a list of 12 words and is asked to recall them immediately after hearing them. Total possible score is 12 for delayed recall with higher number of words being better.

Time frame: Post lumbar puncture

Cerebrospinal Fluid Levels of AB42

Cerebrospinal fluid levels of the 42 amino acid isoform of the beta amyloid peptide

Time frame: 30 minutes after intervention administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.