And, a separate study, the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL), sponsored by the CSIRO and a number of Australian universities, showed a correlation between elevated cortisol in the blood of a healthy aged population and the subsequent development of Alzheimer’s disease in these individuals.
Both studies were presented at the Alzheimer's Association International Conference (AAIC) taking place this week in Toronto, Canada.
Researchers have found there is increasing evidence of elevated cortisol levels and chronic stress leading to changes in the brain, affecting memory and development of amyloid plaques, as well as evidence of subsequent neural death – the two hallmarks of Alzheimer’s disease.
Actinogen says Xanamem has been specifically designed to inhibit the excess production of cortisol, the “stress hormone”, in the brain.
The AIBL study concluded that targeting ways to lower excess cortisol should be undertaken in battling Alzheimer’s disease in the elderly.
Professor Jeffrey Cummings, director, Cleveland Clinic Lou Ruvo Centre for Brain Health in the United States, said the AIBL study results demonstrated “both the importance of understanding the pathological processes in Alzheimer’s and the compelling need for new approaches to treatment”.
“To my eyes, AIBL has provided the most important validation to date for controlling excess cortisol production in individuals at risk for developing dementia. Development of new therapies to inhibit cortisol can show us the impact of blocking this mechanism on disease progression.”
This year the Australian-listed Actinogen Medical (ASX:ACW), initiated XanADu, the company’s global phase II clinical trial investigating Xanamem as a treatment for mild Alzheimer’s disease.
XanADu is being conducted at trial sites in the US, Australia, and the UK, with the primary efficacy endpoints of improvements in scores on the Alzheimer’s Disease Composite (ADCOMs) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) version 14 tests.
The clinical trial is expected to enrol patients in the second half of this year.
“The findings from the AIBL study, linking excess cortisol with the development of Alzheimer’s disease, provides further strong validation of our ongoing development of Xanamem,” said Dr. Bill Ketelbey, chief executive of Actinogen Medical.
“Independent validation is clearly emerging that excess cortisol is a key target for treating the disease and our XanADu trial aims to demonstrate that inhibiting cortisol in the brain with Xanamemis an effective treatment option for patients with mild Alzheimer’s disease.
“It’s particularly exciting to receive this endorsement of Xanamem’s novel mechanism of action as Alzheimer’s is a disease where new approaches to its management are desperately needed to help millions of people worldwide.”