Study of Nasal Insulin to Fight Forgetfulness - Device Study

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

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.

It had two arms (groups): Insulin first, then placebo (experimental) and Placebo first, then insulin (experimental).

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.

The registry classes the interventions as device, drug and other.

More on the Plan

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.

Participants who are cognitively normal or who have aMCI (n=30) will be enrolled.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 55 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: A diagnosis of dementia; 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-04-12 with completion listed for 2019-09-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): CSF Insulin Levels (time frame: 30 minutes after intervention administration).

It also tracked 4 secondary outcomes, for example The Auditory-Verbal Learning Test (AVLT), CSF Levels of AB42, CSF Levels of Total Tau and CSF Levels Phospho-tau 181.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.