- DTHR-ALZ is a development-stage prescription digital therapeutic for patients with Alzheimer’s disease.
- Digitally delivers Reminiscence Therapy to patients with Alzheimer’s disease and automatically optimizes the therapy using biofeedback from the patient using AI.
- Intended to mitigate the symptoms of agitation and depression associated with Alzheimer’s disease.
- Granted Breakthrough Device designation by the FDA in August 2018. Click to view press release.
- If granted approval, DTHR-ALZ would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer’s disease.
- Not yet available for commercial use in the U.S.
What is a Breakthrough Device?
Defined by the FDA to be a device that may be more effective at treating or diagnosing a life-threatening or irreversibly debilitating disease or condition compared to the current standard of care.
The Breakthrough Devices program is a provision of the 21st Century Cures Act
FDA works with medical device developers to expedite regulatory review to give patients more timely access to critically needed diagnostic or therapeutic devices.
What is Reminiscence Therapy?
Reminiscence Therapy is an evidence-based psychosocial intervention that has been shown in clinical trials to improve symptoms of Alzheimer’s disease.
Its adoption has been limited because it is typically labor intensive and difficult to deliver to large populations of patients.