New Study Using Aptar's Nasal Drug Delivery System Validates Insulin Nasal Spray to Deliver Alzheimer's Drug Directly to the Brain
Research by Wake Forest University School of Medicine provides a crucial method for future Alzheimer's disease treatment trials and reveals key differences in how the drug is absorbed in people with early cognitive decline
AptarGroup, Inc. (NYSE:ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announced that its nasal drug delivery system was used in a recently published brain imaging study from Wake Forest University School of Medicine. According to the university's press release, the "groundbreaking" study confirms a vital step toward new Alzheimer's treatments: intranasal insulin, delivered via nasal spray, safely and effectively reaches key memory regions of the brain in older adults. The study also revealed that people with early cognitive decline may absorb it differently.
This research, published in Alzheimer's & Dementia: Translational Research & Clinical Interventions, describes the results of a milestone positron emission tomography (PET) imaging study. According to the Wake Forest team, the results directly show that intranasal insulin travels to 11 key brain regions associated with memory and cognition. Previously, researchers faced challenges in earlier intranasal insulin trials because they could not confirm if the treatment was reaching its brain targets.
The imaging protocol used a precision nasal delivery system supplied by Aptar Pharma, and could be adapted for other intranasal therapies targeting neurological disorders.
"The results of the study represent a significant step forward in medicine as they validate that our nasal delivery system was effective in delivering intranasal insulin safely and effectively to specific regions of the brain," said Reenal Gandhi, Aptar Pharma's Director of Business Development. "Aptar has over 30 years of experience in nasal drug delivery system, including in the area of neurodegenerative diseases, and the patient is at the center of everything we design. While we have nasally delivered medications in emergency and routine care, we believe that the nasal route holds potential for more developments. As scientific understanding and development advance, we see continued opportunities for intranasal delivery to improve how therapeutics are delivered to the central nervous system."
"This study fills a critical gap in our understanding of how intranasal insulin reaches the brain," said Suzanne Craft, Ph.D., professor of gerontology and geriatric medicine at Wake Forest University School of Medicine and director of the Wake Forest Alzheimer's Disease Research Center. "We needed direct evidence that the drug is able to reach key brain targets. An unexpected finding was the observation that uptake may differ in people with early cognitive decline. This means we now have a roadmap directly to the brain."
The Wake Forest study involved 16 older adults (average age 72), including seven who were cognitively normal and nine with mild cognitive impairment (MCI). Using a novel radiotracer, [68Ga]Ga-NOTA-insulin, delivered with a specialized six-spray nasal system, participants underwent a 40-minute brain PET scan followed by whole-body imaging. Participants described the nasal spray as "surprisingly easy."
The researchers found:
- Elevated insulin uptake in critical memory and cognition areas, including the hippocampus, olfactory cortex, amygdala and temporal lobe.
- Cognitively normal individuals showed higher uptake and distinct timing patterns of insulin delivery compared to those with MCI, who exhibited rapid initial uptake followed by quicker clearance.
- In women, insulin uptake correlated strongly with factors linked to healthy cardiovascular function and elevated ptau217 levels (a marker of brain amyloid, the sticky protein that accumulates in the brain in Alzheimer's disease) were associated with decreased brain absorption across multiple regions.
- Only two participants reported mild headaches post-scan, which resolved within 24 hours, indicating the procedure was well-tolerated.
"One of the biggest challenges in developing treatments for brain diseases is getting agents into the brain," Craft said. "This study shows we can validate intranasal delivery systems effectively, an essential step before launching therapeutic trials."
Given recent concerns around the limited efficacy and side-effect profiles of some anti-amyloid drugs, this validation strategy supports a broader approach to Alzheimer's treatment, including metabolic and delivery-focused interventions. The findings could help explain why some patients respond better to intranasal insulin therapy than others, potentially leading to personalized treatment approaches.
"There's an urgent need to identify effective and feasible ways to prevent and treat Alzheimer's dementia," said Craft. "These findings show that we can now validate whether treatments are actually reaching their intended brain targets, which is critical information for designing successful trials."
The Wake Forest team is now planning larger validation studies within the next 12-18 months to explore how vascular health, amyloid accumulation and sex differences influence brain insulin delivery.
"While there's still a lot to learn, these findings show that we now have the tools to validate intranasal drug delivery to the brain," Craft said. "This is promising news for developing more effective and accessible treatments for Alzheimer's disease."
Aptar offers a full range of Orally Inhaled and Nasal Drug Product (OINDP) systems and services to support this growing sector. Aptar offers advanced intranasal drug delivery services, including everything from manufacturing, formulation development all the way through to clinical and commercial product manufacturing. Aptar's nasal spray systems are designed to reliably deliver precise nasal drug dosing in an easy to use, safe, and portable package for both systemic and local administration with rapid onset capabilities.
About Aptar
Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world's leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.
This press release contains forward-looking statements, including the potential outcomes of the nasal delivery system for intranasal insulin. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of words such as "expects," "anticipates," "believes," "estimates," "future," "potential," "continues" and other similar expressions or future or conditional verbs such as "will," "should," "would" and "could" are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Form 10-K and Forms 10-Q. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.
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