Q301--Blood Assays for Alzheimer's

STATEMENT OF WORK 1.0 INTRODUCTION/BACKGROUND: 1.1 We discovered that normal, healthy aging in the absence of neurodegenerative disease is associated with decline in the metabolism of the anterior cingulate cortex (ACC), a region of the brain supporting important cognitive functions such as selective attention. Furthermore, the metabolism in the ACC appears to mediate the relationship between age and attentional performance. The pathophysiology of these phenomena are entirely unknown but could provide insights into age-associated cognitive decline. 1.2 Redox stress is universally observed associated with aging from prokaryotes to humans. One hypothesis is that the high rates of metabolism occurring in the ACC result is oxidative free radicals as an outcome of oxidative metabolism. If so, ACC hypometabolism should correlate with oxidative stress as measured with the redox potential from spectroscopic measurements of healthy participants. This hypothesis, if supportive, would motivate clinical trials using antioxidants such as nicotinamide riboside. We are also exploring this relationship in PTSD participants, to examine the effect of such stress on healthy aging. 2.0 OBJECTIVE: 2.1 The objective of this study is to define normal aging related changes in the human brain to chart where pathology occurs. This will be done with MRI imaging and PET/CT scans on normal human participants. To determine that older participants are exhibiting normal aging, and not undergoing disease-related aging symptoms (eg. from Alzheimer’s, dementia, or other neurodegenerative disease), our team assesses cognitive health with chart reviews and normed neurocognitive assessments. 2.2 To eliminate the influence of preclinical Alzheimer’s on our results, it is necessary to utilize available blood tests to assess Alzheimer’s risk. These blood tests will consist of APOE and p-Tau 231, which sensitively differentiate amyloid positive from amyloid negative cognitively intact patients. 3.0 Scope: 3.1 The contractor shall provide all resources as necessary to accomplish the deliveries described in this Statement of Work except as may otherwise be specified to include using unique instrumentation, expertise, and infrastructure to enable the faculty, trainees, and staff to accomplish the planned work. 3.2 The contractor shall be required to conduct blood testing on samples provided by the VA. 3.3 Specific Tasks 3.3.1 The human specimen will be labeled by the VA and given a randomized number separate from participant’s ID number. 3.3.2 The blood sample will be collected by the government personnel at the VA Medical Center (1 Veteran’s Drive, Minneapolis, MN 55417) and will ship the required volume to the contractor express on dry ice. 3.3.3 Contractor Tasks: 3.3.3.1 The contractor shall process the blood samples using APOE and pTau217. 3.3.3.1.2 Perform tests in vendor’s lab using pre-frozen 1.5mL EDTA plasma/ buffy coat/ 1.5mL red blood cells or extracted DNA, that has been stored at -80 for up to a year. 3.3.3.1.3 Perform samples as individually received (not batched) and provide pTau results in ng/mL 3.3.3.2 The contractor shall deliver sample test results to the VA study team () within 15 days of receiving the sample. 3.3.3.3 The contractor shall notify the study team within 10 days upon receipt of insufficient sample (defective, incomplete, or otherwise do not meet vendor requirements), along with the reason for insufficiency. 4.0 Contractor Qualifications 4.1 For the Contractor to accomplish the work under this task order/purchase order, it shall be necessary for the Contractor to have the following qualifications: 4.1.1 Have published evidence of their ability to perform repeatable and validated APOE and pTau217 blood tests 4.1.2 Have expertise in providing accurate and sensitive APOE and ptau-217 assays 4.1.3 Have a valid Clinical Laboratory Improvement Amendments (CLIA) certificate or other relevant lab certifications 5.0 Other requirements: 5.1 Invoicing 5.1.1 Invoices will be generated at the end of each month in which samples are processed. 5.2 Task orders 5.2.1 Task Orders will be requested as needed, defining the clin item, quantity, and dollar amount will be identified within each task order. 5.2.2 Task Orders will contain funding and a Purchase Order number for invoicing. 5.2.3 No services shall be performed without a funded task order. 5.2.4 Estimated Quantity for the entire Period of Performance of the Contract Description Number of Samples for Blood Assay Year 1 25 Year 2 25 Year 3 25