New Clinical Trial Shows Promise for Early Alzheimer’s Treatment

A recent clinical trial has explored the effects of a diabetes medication alongside an insulin nasal spray. The findings suggest that both treatments can safely address different aspects of mild cognitive decline associated with early Alzheimer’s disease, showing no harmful side effects.

Alzheimer’s and various types of dementia are complicated conditions requiring multiple treatment strategies for effective management. The two medications in this trial work on different biological mechanisms. Empagliflozin, a known diabetes drug, reduces inflammation—a factor linked to the onset of Alzheimer’s. The insulin nasal spray targets the brain directly, helping to keep brain cells healthy.

Conducted in the US, this trial included 47 older adults aged between 55 to 85, with 42 participants completing the treatment. All individuals either had mild cognitive impairment or mild dementia, or were showing molecular changes related to Alzheimer’s.

Participants received either empagliflozin alone, the insulin spray alone, both medications together, or a placebo for four weeks. While the trial size was too small to establish statistically significant differences—its primary focus was on safety—some interesting trends did emerge.

Neuroscientist Suzanne Craft from Wake Forest University noted that, for the first time, they saw empagliflozin reduce signs of brain injury while improving blood flow in key brain areas. She also emphasized the benefits of delivering insulin directly to the brain, which appeared to boost cognition and neurovascular health.

Empagliflozin enhances the body’s management of glucose and sodium, resulting in lower inflammation, reduced cellular stress, and improved energy efficiency. In this trial, it successfully lowered levels of tau protein in cerebrospinal fluid, a protein that can form harmful clumps in Alzheimer’s patients, while also benefiting blood flow and cholesterol levels.

The selection of the insulin nasal spray came from its known associations with Alzheimer’s, and prior studies indicated that insulin could positively impact brain function. Participants who received the spray performed better on cognitive tests that evaluated memory and thinking. Brain scans also revealed improvements in white matter connectivity and blood flow related to memory.

Metabolism plays a crucial role in overall health, and these treatments focus on that early stage, rather than just the later, more severe effects typically seen in established Alzheimer’s cases. Craft suggested that targeting metabolism might change the trajectory of Alzheimer’s disease, highlighting it as a significant area for future treatment.

This trial was a preliminary investigation designed to expand on earlier findings and evaluate safety. Although more extensive testing is necessary to determine the true effectiveness of these medications against Alzheimer’s, the initial results are promising, indicating a beneficial balance between enhancing immune responses and reducing the risks associated with excessive inflammation.

Looking ahead, Craft mentioned plans for larger studies involving individuals with early and preclinical stages of Alzheimer’s. She expressed optimism that these treatments, whether used alone or in combination with existing therapies, could provide meaningful therapeutic advantages.

The research was published in the journal Alzheimer’s & Dementia.