Mechanisms of Insulin Facilitation of Memory

What Was Tested

This registered not phased trial tested Insulin (regular human).

Successful completion of this study may set the stage for a larger-scale treatment trial of intranasal insulin for adults with memory disorders.

It had two arms (groups): insulin (experimental) and Saline (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Insulin and placebo conditions will be counterbalanced across participants.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Clinical diagnosis of probable AD. Age over 21. Clinical Dementia Rating of 0.5 or 1.0. Mini Mental State Exam Score\>15.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: preexisting diabetes; severe head injury with loss of consciousness \> 30 minutes or with permanent neurological sequelae; current use of anti-psychotic or anti-convulsant medications.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

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

It started in 2010-07 with completion listed for 2014-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Cerebral Glutamate Concentration (time frame: 15 minutes post insulin or placebo administration).

It also tracked 1 secondary outcome, for example Memory.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 12 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.