This blog will provide you with context and insight on Alzheimer’s Disease clinical research and how technology and the use of digital biomarkers will be invaluable to prevention and treatment initiatives.
Here is the background…
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).
Robust and evolving research in new medications and identifying disease biomarkers continues to tackle the mission of NAPA. What other solutions could enhance and accelerate our understanding of ADRD?
What is the importance of the intersection of biomarkers and technology?
We think of a biomarker as molecular or histologic, but they also include radiologic and physiologic, i.e., A blood pressure result after the start of a new antihypertensive treatment. Now utilizing technology the development of digital biomarkers is here. How can technology capture and validate data that informs us of disease progression, regression, efficacy of treatment, or a new clinical trial medication. Will these data demonstrate subtle disease progression, or identify new stages of disease not seen before, spurring earlier identification, treatment and spurring new interventions and treatments.
Why is this so important?
It’s all about the data. When I worked in the Bio-Pharma arena, manually chasing Case Report forms, or writing Note to Files or locating missing assessments, slows down clinical trial endpoints, efficacy, and FDA approval, and more importantly, access for patient’s. Being able to have digital capture now can provide physiological, functional and behavioral evaluation, of ADL’s for example, and provide another layer of validation, is a dream solution to gasp in data… this is absolutely huge and significant. Yes I am talking about the use of wearable digital technology, AI, algorithms and predictive analytics not only to identify the patient’s ADL behavior but recognize the changes in functioning through machine learning. This arms our researcher’s and healthcare providers with validated information on how that patient is responding to treatment, or progression of their disease.
Boom, a total game changer… utilizing digital technology to support, and enhance efficacy of the healthcare team and health systems, keeping our precious seniors safer in the community, wherever they live!
According to NIH/NI/NINDS 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. This is the ‘Achilles-Heel of the industry and broadens the scope, outreach and enrollment for home based disease research and pharmaceutical clinical trials. 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”.
My fundamental concern as you know is, “How do we take care of seniors, wherever they live?” Digital Health Technology, is the future, and now has a home, literally and figuratively!