Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease

What Was Tested

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

The purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.

It had three arms (groups): Insulin and Empagliflozin Matching Placebo (experimental), Empagliflozin and Insulin Matching Placebo (experimental) and Double Placebo (experimental).

Placebo for intranasal insulin and placebo for empagliflozin as add-on treatment to anti-amyloid therapy.

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 55 years up to 85 years.

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

Examples of who could join: Fluent in English. Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment. Amyloid positive by PET or cerebrospinal fluid criteria. Stable medical condition for 3 months prior to screening visit. Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician).

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: A diagnosis of dementia other than Alzheimer's disease; diabetes (type i or type ii) insulin dependent and non-insulin dependent diabetes mellitus; current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2026-11 with completion listed for 2028-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of treatment-related serious adverse events (time frame: Month 6).

It also tracked 4 secondary outcomes, for example Alzheimer's Disease Assessment Scale-Cognition Score, Modified Preclinical Alzheimer Cognitive Composite 5 Score, Montreal Cognitive Assessment Score and Clinical Dementia Rating Scale Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 30 people.

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

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.