SNIFF Multi-Device Study 2

Phase 2

Suspended

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.

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.

Recruitment & 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Locations (1): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States

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