DTHR-ALZ Receives Breakthrough Device Designation for Alzheimer Disease

The FDA granted breakthrough device designation to Dthera Sciences development-stage product DTHR-ALZ, which is intended to mitigate agitation and depression associated with Alzheimer disease.

If granted approval, DTHR-ALZ would be the first non-pharmacological prescription treatment for this indication. DTHR-ALZ is a development-stage prescription digital therapeutic that digitally delivers Reminiscence Therapy, automatically optimizing the therapy using biofeedback from the patient through artificial intelligence.

“This breakthrough designation has provided us with a remarkable opportunity to expedite the development of our digital therapeutic device,” Martin Culjat, PhD, vice president of scientific and regulatory affairs, Dthera Sciences, said in a statement.¹ “We feel deeply honored that the FDA has confirmed DTHR-ALZ meets the requirements for this designation, and we are eager to work together with the FDA throughout this process.”

The therapy is delivered through a custom-built tablet with a front-facing camera and displays content like photos of loved ones or memories uploaded by the patient’s family. The device uses artificial intelligence to automatically optimize therapy based on several forms of biofeedback from the patient, adjusting content on screen to guide the viewer’s emotions, reducing or preventing agitation. The science behind this therapy is reminiscence therapy, an evidence-based psychosocial intervention that involves the introduction of familiar pictures, music or other materials to help individuals reminisce on past experiences. DTHR-ALZ is not currently available for commercial use in the U.S.

In addition to the DTHR-ALZ product, Dthera Sciences has developed another product that shares many similarities, ReminX, the company’s consumer product.² The online-based story-sharing platform, along with reminiscence therapy, allows users to record audio over photos as a way to share memories with family members suffering from a neurological or psychiatric condition.

A clinical proof-of-concept study was performed for the in-home use of ReminX for individuals with mild-to-moderate dementia. The study examined the impact the ReminX digital therapeutic software system had on emotional functioning in 14 participants with mild-to-moderate dementia.

Researchers assessed participants at home, evaluating questionnaires that measured levels of depression, anxiety and overall emotional distress. Participants’ caregivers were also asked to rate the participant’s level of emotional functioning using a caregiver-based questionnaire.

Caregivers were to upload story content onto mobile devices using the app, and stories were created and displayed on the patient tablet in the form of slideshows. Participants viewed the slideshow and were immediately reassessed through the same set of questionnaires as prior to the viewing.

Outcome measures evaluated included the Emotional Thermometer (ET); State subset of the State/Trait Anxiety Inventory (STAI); Hospital Anxiety and Depression Scale (HADS); Neuro-QOL Depression Scale-Modified (NQOL); and Caregiver Questionnaire (CQ).

Data indicated that the software led to an immediate and significant decrease in anxiety, depression and overall emotional distress after viewing customized stories. Patient’s caregivers also reported that the participant appeared less emotionally stressed. The results show that participant’s scores were significantly lower post-viewing compared to pre-viewing on the ET (1.96 vs. .39), STAI (35.36 vs. 29.64), HADS (9.14 vs. 5.28) and CQ (9.63 vs. 5.28) (P <.05), but not the NQOL (42.21 vs. 39.14).

ReminX is readily accessible and can be utilized by patients on an ongoing basis.

REFERENCE

1. Dthera Sciences Receives FDA Breakthrough Device Designation For Its Alzheimer's Focused Development-Stage Product "DTHR-ALZ” [news release]. San Diego, Calif.: Dthera Sciences; August 23, 2018. https://www.prnewswire.com/news-releases/dthera-sciences-receives-fda-breakthrough-device-designation-for-its-alzheimers-focused-development-stage-product-dthr-alz-300701487.html. Accessed August 23, 2018.

2. Filoteo J, Cox E, Split M, et al. Evaluation of ReminX as a Behavioral Intervention for Mild to Moderate Dementia. Paper presented

at:

40^th Annual International Conference of the IEEE Engineering in Medicine and Biology Society; May 3, 2018; Honolulu, HI. http://dthera.com/wp-content/uploads/2018/07/ReminX-IEEE-EMBC-Publication.pdf. August 23, 2018.