Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days

What Was Tested

This registered phase 2 trial tested Insulin Detemir.

The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI).

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), one (experimental) and one (experimental).

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.

The investigators 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.

However, that particular method would not be a practical intervention for people with Alzheimer's disease due to the risk of hypoglycemia or exacerbation of insulin resistance.

Who Took Part

The registry lists 60 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 9 exclusion criteria; among the exclusions: excessively high or low blood pressure, heart rate; BMI greater than 34; pre-existing diabetes not controlled by exercise.

How the Study Was Run

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

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

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

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

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

It started in 2011-03 with completion listed for 2012-12.

It ran at 1 site in United States.

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 3 Weeks).

It also tracked 6 secondary outcomes, for example Neuropsychological Test of Executive Function 1, Glucose Tolerance, Functional Ability, Plasma biomarkers of AD, Neuropsychological Test of Executive Functioning 2 and Neuropsychological Tests of Visual Working Memory.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Detemir in 60 people.

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

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