Device to Spot Alzheimer’s Onset in Adults Recognized by FDA
Altoida’s artificial intelligence (AI)-powered device, intended to indicate the start of Alzheimer’s disease in adults with mild dementia but no evident disease symptoms, has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA).
The non-invasive device uses a software that measures and monitors neurocognitive function to diagnose and distinguish Alzheimer’s disease from other disorders. These include mild cognitive impairment (MCI), a neurological disorder marked by subtle changes in memory and considered a risk factor for Alzheimer’s.
“We are proud to receive this designation for the Altoida device, which will be a completely digital solution for predictive Alzheimer’s disease diagnosis,” Travis Bond, CEO of Altoida, said in a press release.
“We look forward to working with the FDA to continue development of our device and to make highly accurate, non-invasive, and cost effective diagnosis of neurodegenerative disorders universally accessible, beginning with Alzheimer’s disease,” Bond added.
Called a precision neurology device, it uses AI and measures 800 digital biomarkers, totaling 11 unique neurocognitive domains, to indicate Alzheimer’s before symptom onset.
The device collects data while users complete a 10-minute set of augmented reality and motor activities on a smartphone or tablet. “Our augmented reality activities feel like games, not tests,” Altoida reported on a webpage.
With the help of AI, it aims to help predict whether individuals 55 or older with MCI will progress to Alzheimer’s disease within a year.
“We have devoted more than twenty years of research to reinventing traditional approaches in dementia diagnosis,” said Ioannis Tarnanas, PhD, chief scientific officer of Altoida.
According to the press release, Altoida and Eisai have partnered to accelerate work on predictive dementia diagnostics. Funding through this partnership will aid in further research and the potential commercialization of Altoida’s products.
Breakthrough device designation is given to accelerate the development and review of devices or device-led combination products that might more effectively treat or diagnose life-threatening or irreversibly debilitating diseases.
The program’s features include more intensive FDA guidance throughout development — such as ensuring efficient design of clinical testing — and eligibility for priority review.
“This designation is recognition of the strong clinical need to accurately and reliably predict conversion to Alzheimer’s disease before irreversible damage can occur,” Tarnanas said. “Altoida’s device could enable predictive diagnosis of neurodegenerative disorders at the population level, which can in turn enable preventative and therapeutic intervention in the earliest stages.”