Memory and Insulin in Early Alzheimer's Disease

What Was Tested

The trial (phase 1, phase 2) is built around Insulin Aspart.

It had two arms (groups): Intranasal Insulin Aspart (experimental) and Intranasal Saline (placebo) (active comparator).

Participants were administered intranasal saline (placebo) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

The registry classes the interventions as drug.

More on the Plan

The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Who Took Part

31 actual participants took part.

It was open to people of any sex aged from 60 years with no upper age limit.

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

Examples of who could join: Patients with Early Alzheimer's disease.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients with late alzheimer's disease.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2007-10 with completion listed for 2012-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): fMRI Measure of Hippocampal Activation (time frame: 30 minutes After Intervention Administration).

It also tracked 1 secondary outcome, for example Global Cognition.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Aspart in 31 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 Aspart compound page, all human trials.