A research team led by Suzanne Craft, professor of psychiatry and behavioral sciences at the University of Washington based at the VA Puget Sound Health Care System, has found that a four-month pilot trial of insulin nasal spray therapy shows improvement in memory, cognition and daily functioning among 104 study participants with mild cognitive impairment and mild to moderate Alzheimers disease.
Treatments were administered through an innovative device that quickly delivered the insulin to the brain. No side-effects were reported. The results were announced today at the Alzheimers Disease Research Summit 2012: Path to Treatment and Prevention taking place at the National Institutes of Health in Bethesda, Md.
Craft reported that growing evidence points to insulin playing a vital role in brain function, with decreased levels possibly contributing to memory problems, atrophy and other Alzheimers-related brain changes. She said scientists believe that normalizing brain insulin levels might be beneficial in treating the disease.
A new, larger study is planned that will recruit 240 volunteers for a year-long treatment trial at multiple sites across the U.S. Study participants with mild cognitive impairment or mild Alzheimers dementia will receive insulin treatment or a placebo.
At the end of one year, researchers will compare cognition, memory and functional performance between the two groups. Additionally, biomarkers associated with Alzheimers disease (levels of tau and amyloid proteins) will be measured in cerebrospinal fluid, and Alzheimers associated brain atrophy will be measured through brain imaging. At the end of the study year, all participants will receive the nasal insulin spray for 6 months.
The trial will be conducted in collaboration with the Alzheimers Disease Cooperative Study Consortium, a National Institute on Aging-supported network of academic medical centers and clinics experienced in designing and conducting Alzheimers clinical trials.
“This study allows more definitive testing of a promising treatment for Alzheimers disease,” said Laurie Ryan, program director of Alzheimers Clinical Trials at the National Institute on Aging at NIH, the lead institute studying age-related cognitive decline. “This larger, more in-depth clinical trial of insulin nasal spray will be a significant step forward in understanding the safety and effectiveness of this approach.”
Craft was the lead author of a study published in the Archives of Neurology in September 2011 that found low doses of insulin delivered to the brain through nasal sprays helped improve memory in people with mild cognitive impairment and early Alzheimer’s disease.
A push to find new treatments and preventions for Alzheimer’s disease is the focus of this weeks Alzheimers Disease Research Summit, the largest-ever government-sponsored summit for the disease that has brought together nearly 600 researchers from around the world.
More than 5 million people in the US have Alzheimer’s disease, and the numbers are expected to grow. This week’s program is a result of plans established by the National Alzheimer’s Project Act, signed into law by President Obama last year and expected to be finalized today at the summit. The top goal is to find a cure for Alzheimers Disease by 2025.