Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart

What Was Tested

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

This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition, daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid deposition in the brain.

Participants will be randomly assigned to receive insulin aspart or placebo during a 12-week treatment period.

It had two arms (groups): Insulin Aspart (experimental) and Placebo (placebo comparator).

Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.

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.

All participants will appoint a "support person" to answer a collateral questionnaire and supervise the administration of the study drug.

All participants and study partners will undergo the intensive, structured training program in the self-management of intranasal insulin administration.

Cognitive testing and blood collection will occur at baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 50 years up to 89 years.

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

Examples of who could join: Previous or subsequent diagnosis of Alzheimer's disease or mild cognitive impairment. Ability to communicate in English.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: preexisting diabetes; current use of antipsychotic, anticonvulsant, anxiolytic, anticoagulant or sedative medications; current or previous use of glucose-lowering agents or insulin;.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Aspart 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 Aspart 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 2015-03-20 with completion listed for 2019-04-16.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in cognition (time frame: 6 weeks and 12 weeks).

It also tracked 2 secondary outcomes, for example Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers and MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 24 people.

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

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

More context: the Insulin Aspart compound page, all human trials.