Empagliflozin + Insulin for Alzheimer's Disease

(REVITAA-ALZ Trial)

This trial explores how insulin and Empagliflozin (a drug used to lower blood sugar) affect individuals with mild memory issues or early Alzheimer's who are already receiving treatment targeting brain plaques. The goal is to determine if these medications can improve symptoms compared to a placebo (a pill with no active medicine). Participants should have mild cognitive impairment or early Alzheimer's and must be stable on their current treatment for at least eight weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Earlier studies have shown that empagliflozin is safe and well-tolerated. One study found it lowered the risk of dementia and improved heart health by reducing deaths and hospital visits for heart failure. Another study found that empagliflozin helped improve brain health by lowering harmful brain proteins in Alzheimer's patients.

Researchers are excited about these treatments for Alzheimer's disease because they combine empagliflozin and insulin, which offer a fresh approach compared to the current standard treatments like cholinesterase inhibitors and memantine. Empagliflozin, typically used for diabetes, may help improve brain energy metabolism, which is a new angle in Alzheimer's care. Additionally, the use of intranasal insulin is intriguing because it could enhance insulin signaling directly in the brain, potentially improving cognitive function. This combination therapy is distinctive in its dual approach to potentially address both metabolic and cognitive aspects of Alzheimer's disease.

This trial will compare the effects of insulin and empagliflozin on Alzheimer's disease. Research has shown that using insulin through a nasal spray has produced mixed results in aiding memory and thinking skills. Some studies found it improved memory, particularly in recalling stories, while others observed little benefit. Brain scans confirmed that this insulin safely reaches key memory areas in the brain, offering hope for Alzheimer's treatment. Participants in one arm of this trial will receive intranasal insulin with a placebo for empagliflozin.