Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)

What Was Tested

The trial (phase 2) is built around Insulin (regular human) and Insulin Detemir.

The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain functions, and that insulin dysregulation can contribute to AD pathogenesis.

It had three arms (groups): Saline (placebo comparator), Insulin Detemir (experimental) and Insulin (experimental).

Saline placebo taken twice per day via intranasal route.

The registry classes the interventions as drug.

More on the Plan

It is well-known that insulin, a hormone that is naturally secreted by the pancreas, plays an important physiological role by regulating blood sugar levels in the body.

Researchers now know that insulin plays many important roles in the brain as well.

Insulin seems to be especially active in the part of the brain that corresponds to learning and memory.

Instead, the investigators use an "intranasal" method of administration, in which the insulin is inserted into a device, and administered intranasally.

Who Took Part

The registry lists 37 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: Diagnosed with mild cognitive impairment, or mild/moderate AD.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: excessively high or low blood pressure, heart rate; pre-existing diabetes not controlled by exercise/diet; previous/current use of insulin.

How the Study Was Run

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

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.

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

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 2011-11 with completion listed for 2015-03-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Verbal Memory Composite (time frame: Change from Baseline in Verbal Memory at 16 weeks).

It also tracked 4 secondary outcomes, for example Cerebral Spinal Fluid (CSF) Biomarkers of AD, Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio and Functional Ability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Insulin Detemir in 37 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 and the Insulin Detemir compound page, all human trials.