SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days)

What Was Tested

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

It had three arms (groups): 1 (placebo comparator), 2 (experimental) and 3 (experimental).

Saline.

The registry classes the interventions as drug.

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.

Who Took Part

The registry lists 173 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 55 or greater. Good physical health. Memory impairment with a diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: chronic sinus problems/allergies with chronic use of nasal decongestants or antihistamines; major psychiatric disorders (e.g., untreated major depression and schizophrenia); chronic use of the following types of medications: anti-psychotic, anxiolytic, and opiates.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

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

It started in 2006-06 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in cognition (time frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)). glucose metabolism (time frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)). plasma biological markers (time frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)).

It also tracked 2 secondary outcomes, for example CSF biological markers and cerebral glucose metabolism.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 173 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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