Highly Scalable and Cost-Effective Home-Based Sampling and Testing Solution for Glymphatic Clearance/Impairment in TBI Veterans at Risk for Alzheimer s Disease
Abstract
Focus Area: Military Service Members are at particular risk of traumatic brain injury (TBI) because of sudden trauma, which causes damage to the brain, though TBI occurs in civilians too. Evidence suggests that brain injury triggers pathological outcomes that could manifest into Alzheimer’s disease (AD) and AD-related dementias over time. This project addresses the Fiscal Year 2022 Peer Reviewed Alzheimer’s Research Program Accelerating Diagnostics Research Award Focus Area Diagnostic, environmental, and prognostic factors by performing research that will enable better detection, diagnosis, and treatment of AD following military Service and/or TBI. Objectives and Rationale: Decades of unsuccessful attempts to cure AD and late-stage dementia have resulted in a paradigm shift to focus on the more challenging aspect of preventing dementia. AD is thought to begin in asymptomatic individuals with no clinical evidence of disease activity; however, detection of such individuals is currently challenging and cost prohibitive. We have identified blood biomarkers, i.e., biological molecules in the blood that can be used in blood tests to diagnose AD at a very early stage and/or to monitor disease progression. Developing home-based blood tests for AD may therefore be feasible and is crucial to identify at-risk individuals and to define optimal treatment windows for early interventions. The objective of this study is to develop a highly scalable and cost-effective home-based sampling and testing solution to detect AD blood biomarkers for early detection and monitoring of subclinical evidence of disease activity, i.e., detection of AD before clinical evidence or symptoms occurs. This solution, known as Gryphon’s Out of Hospital Sampling and Testing (GOHST) solution, will use plasma samples that are separated from whole blood and dried on filter paper spots after blood is drawn from a finger prick as well as high-sensitivity immunoassays of the spots at a central laboratory to assess blood biomarkers for two frequently co-occurring AD risk factors: sleep-wake disruption and TBI. Clinical Applications and Patients: This project will be of benefit to patients who have suffered a TBI and are therefore at increased risk of developing AD. It will also benefit patients who suffer from sleep disruption, which is common after TBI and similarly increases the risk of AD. The GOHST solution to be developed in this project will provide a way to identify patients with AD before symptoms occur by performing finger-prick blood collection, which can be performed in the comfort of a patient’s home. This will eliminate the need for standard AD diagnostic tests which are invasive (like lumbar puncture for cerebral spinal fluid), and expensive and time-consuming (like magnetic resonance imaging). These tests are also used for monitoring progress of patients with AD, so our GOHST solution will support patient monitoring over time from the comfort of their own homes. In addition, identifying a set of validated blood biomarkers for AD will allow early diagnosis, which will ultimately support early treatment to improve patient outcomes and quality of life. Ongoing patient monitoring using this approach will also support improved clinical decision-making and patient care. Furthermore, our GOHST solution can be used to assess the impact of new therapies for AD, which will ultimately improve clinical utility and care of these patients. The risks of the GOHST solution are minimal – akin to finger stick blood collection for glucose testing of diabetes patients. Timeline: Short-term outcomes that will benefit patients, such as verifying a home-based sampling device for finger-prick blood collection of a set of top-ranked blood biomarkers for early diagnosis of AD should be available at the end of the 3-year project. Longer term outcomes such as improved patient care through early treatment after early diagnosis would likely only be available at a later time fo
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310392
Entities
People
- William Haskins
Organizations
- United States Army