DTHR- ALZ - Product Description
Dthera is developing DTHR-ALZ, a digital therapeutic that digitally delivers reminiscence therapy to Alzheimer’s sufferers in a scalable and personalized manner.
DTHR-ALZ has been granted Breakthrough Device designation by the FDA for the mitigation of the Alzheimer’s symptoms of agitation and depression. DTHR-ALZ is the first product to receive Breakthrough Device designation for the treatment of Alzheimer’s disease, and Dthera is only the second digital therapeutic company to receive this designation.
If granted FDA clearance, DTHR-ALZ would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer’s. The product was nominated by Rock Health as one of the top 4 Best Designed Products in Digital Health in 2018, alongside Apple Watch. Apple Health Records, and Sleep Tuner.
• Evidence-based behavioral intervention that involves the introduction of familiar pictures, music, or other materials to help individuals reminisce about their past experiences
• Shown in clinical trials to have positive impacts on mood, depression, agitation, distress, and other behavioral and psychological symptoms of dementia (BPSD)
• Limited because it is highly labor intensive and challenging to deliver at scale
DTHR-ALZ takes a different approach than traditional reminiscence therapy. DTHR-ALZ can be provided more frequently, with more consistency, in a more personalized manner, and with minimal investment of time and resources than traditional reminiscence therapy.
DTHR-ALZ has been granted Breakthrough Device designation by the FDA.
The Breakthrough Devices program is intended to expedite the regulatory review of innovative technologies that address significant unmet clinical needs.
DTHR-ALZ is the first product to receive Breakthrough Device designation for the treatment of Alzheimer’s disease, and Dthera Sciences is only the second digital therapeutic company to receive this designation.
DTHR-ALZ is not yet cleared by the U.S. Food and Drug Administration (FDA), and is not yet available for commercial use in the U.S
DTHR-ALZ is comprised of three key components:
• Custom computer tablet specifically designed and tested for seniors with Alzheimer’s disease
• Facial expression detection system to assess the reaction to reminiscence content
• Two sided AI that obtains and optimizes therapeutic content being delivered to the patient