Memory Aid by Intranasal Insulin in Diabetes (MemAID)

What Was Tested

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

Four groups will be tested: DM group treated with INI; DM group treated with placebo; control group treated with INI and the control group treated with placebo.

The INI or placebo will be delivered into the nose.

It had four arms (groups): one (experimental), one (placebo comparator), Control - Insulin (experimental) and Control - Placebo (placebo comparator).

Intranasal sterile saline once daily over 24 weeks.

The registry classes the interventions as drug.

More on the Plan

Aim 1: To determine whether INI-treated type 2 DM adults have a) better memory and functioning of specific cognitive domains and b) faster dual-task gait speed and better daily living functioning than the placebo-treated and non-DM groups.

Four groups will be tested: 60 DM subjects treated with insulin; 60 DM subjects treated with placebo; 45 control subjects treated with INI and 45 control subjects treated with placebo.

These 210 patients are expected to complete treatment and 168 are expected to complete study by the study completion anticipated date.

The non-DM groups will provide reference of INI effects in a clinical phenotype of cognitive decline and insulin resistance that occurs with normal aging.

Who Took Part

289 actual participants took part.

It was open to people of any sex aged from 50 years up to 85 years.

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

Examples of who could join: Men and women aged 50-85 years old. Able to walk for 6 minutes. Participants capable of providing informed consent.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: type 2 dm treated with insulin (since 9/25/2017); type 1 dm; intolerance to 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 (regular human) group and the comparison group should start out alike.

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 (regular human).

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

It started in 2015-10-06 with completion listed for 2020-05-31.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Gait Speed Normal Walk (cm/s). Gait Speed Dual-task (cm/s). Executive Function Composite z Score.

It also tracked 2 secondary outcomes, for example Fasting Plasma Glucose (mg/dL) and Weight (kg).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 289 people.

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.