In 2011, the National Alzheimer’s Project Act (NAPA) allocated resources “to prevent and effectively treat Alzheimer’s by 2025.” Since then, the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) have held multiple research summits to assess the needs and opportunities relevant to this goal for Alzheimer’s Disease (AD) and Alzheimer’s Disease Related Dementias (ADRD). In particular, the NINDS has convened expert panels to discuss and to recommend research priorities for advancing the state-of-the-science for the Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD) by 2025. ADRD are defined as Frontotemporal Degeneration (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD) and Multiple Etiology Dementias (MED).
Individuals with ADRD can have many physiological changes that lead to a variety of symptoms and changes in function that negatively impact quality of life but may be difficult to accurately monitor and track through standard clinical outcome assessments. Examples include sleep disorders, such as idiopathic REM sleep behavior disorder (RBD) in LDB, and insomnia and daytime sleepiness in FTD. Likewise, mobility, autonomic dysfunction such as orthostatic hypotension leading to postural instability and falls, as well as gastrointestinal issues, all negatively impact quality of life, but are difficult to accurately track and quantify when relying on self-report or caregiver reports. Use of digital health technologies (DHTs) to enable monitoring in clinical trials as exploratory or secondary endpoints is rapidly increasing. Advantages of using digital endpoints in clinical trials are numerous, including enabling higher frequency longitudinal data collection in real world conditions and reducing the burden of participation in clinical trials, which can increase participant recruitment and retention. However, like all biomarkers and clinical assessments, demonstrating utility and reliability requires extensive fit-for-purpose validation. As described in the FDA’s draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”, evidence must include verification that the device can accurately, and reliability measure the physiological, functional or behavioral characteristics that make up the biomarker(s) or assessments of interest, and also establish the statistical relationship between the changes in the biomarker or assessment with a clinically meaningful change in how the patient feels, functions, or survives. Although Digital Health Technologies (DHTs) are broadly defined as “a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related uses”, the focus of funding opportunities is on developing digital biomarkers and performance/functional assessments from data generated from wearable sensor-based devices.
Receive Text Alerts & Events with Location
1. Place Beacons, 2. Set-up Alerts, 3. Receive Text Alerts
I highly recommend the Wherible device due to an incident that occurred last week with my dad where I wished he had the device on him.
A week ago my 83-yr old dad decided to go outside by himself at 6am to pick up the newspaper which had been dropped at our driveway. My mom and I were sound asleep and had no idea my dad was awake and outside. We were awakened by loud banging sound on our front door. To our surprise it was our next door neighbor shouting that my dad had fallen on the driveway, hurt himself, and needed help to get back up. When I ran over to help him up he mentioned that he had been down on the ground for more than 1/2 an hour. If he had the Wherible device on him, we would have been notified of his fall immediately and could have helped him up sooner.
The Wherible device would definitely be a peace-of-mind for all family members as well as the user.
I have been restricted to my wheelchair since 1985. I was introduced to Wherible by a friend, I said to myself this sounds like a good idea but I’m not sure if it will work for me. I had my friend to order me a device. We followed the instructions and set up the Wherible. I can’t believe it, it works. I’m now able to get back some of my independence. Now if there is a emergency I can press the panic button and the device will within 6O Seconds will be notified my family that I need assistance. The best part about it, if I were to fall, my device will detect my fall and within 60 second notify my family by text or email that I have fallen.
I love my Wherible.
We bought Wherible because mother has a bit of dementia at night. She does not leave the condo without someone with her but lives alone. She has had one fall that Wherible caught and we were thankful we got the alert and called her neighbor. She was rattled but checked out OK. She has a flip phone and can’t text so she uses the Wherible panic button to text us when she needs something or wants to talk. We are 800 miles away but our stress level has been down at night since we got Wherible in March.
My mom lives alone and fell when she was gardening. She broke her cheekbone and fortunately a neighbor was walking his dog and discovered her and got her to the hospital. It would break her heart to quit gardening and she treat those flowers like family. We got her Wherible and she knows to wear it under her blouse for almost a year now with no problems. My brother and I check on her with the app every night to be sure she is at home and that the Wherible device is charged.
The relief in my father’s voice when I called him immediately after he fell was as comforting as me getting the alert when the fall occurred. My aging father is 400 miles away from me. Falls, driving and any other reason he may need help have been a source of stress for years. Wherible has alleviated much of that stress. My dad can push a panic button and I get notified. If he falls I get notified. The GPS allows me to know exactly where my father is located. While he is good about wearing his tracker, thanks to the temperature sensor, I know if he is wearing it or not. This device provides an incredible sense of peace for both my father and I.