Methods of determining a treatment protocol for and/or a prognosis of a patient's recovery from a brain injury
Inventors
Wilson, David • Zetterberg, John Henrik • Blennow, Kaj • Randall, Jeffrey D.
Assignees
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Publication Number
US-10393759-B2
Publication Date
2019-08-27
Expiration Date
Abstract
The present invention, in some embodiments, generally relates to methods of determining a treatment protocol for and/or a prognosis of a patient's recovery from a brain injury. In some embodiments, the brain injury results from a hypoxic event. In some embodiments, methods are provided for determining a measure of the concentration of tau protein in a patient sample containing or suspected of containing tau protein.
Core Innovation
The invention determines a prognosis of a patient's recovery from a brain injury by measuring tau protein concentration in serial blood samples, or plasma or serum derived from those samples. It uses the concentration measurements over time to determine an area under a curve for the total period and/or a second peak, and bases a prognosis and/or method of treatment on that area.
A further independent method determines a measure of tau protein from serial blood or blood-derived samples after brain injury and determines the corresponding area under the concentration-versus-time curve. The supplied partial content does not include the background section, so the problem described there is not explicitly available. Details of assay operation are omitted for safety.
Claims Coverage
The two independent claims are claims 1 and 18. Together, they cover three main inventive features: determining a brain-injury recovery prognosis or treatment from tau concentration over time, measuring tau in serial samples with single-molecule sensitivity, and determining an area under the concentration-versus-time curve.
Brain-injury prognosis based on tau concentration over time
Claim 1 determines a prognosis of a patient's recovery from a brain injury and/or a method of treatment based on an area under a curve of tau concentration measurements over time. The area is determined for the total period and/or a second peak.
Single-molecule measurement of tau in serial samples
Claims 1 and 18 measure tau protein concentration in multiple blood samples, or derived plasma or serum, collected following brain injury. The assay provides single-molecule-level detection; assay operation is [procedural detail omitted for safety].
Area under the tau concentration curve
Claims 1 and 18 determine an area under a graph of tau protein concentration measurements versus time, for the total period and/or a second peak. Claim 18 covers determining this measure and area, while claim 1 uses the area to determine prognosis and/or treatment.
The independent claims cover serial tau measurement after brain injury and analysis of the resulting concentration-versus-time area. Claim 1 further links that area to a recovery prognosis and/or treatment, while claim 18 focuses on determining the tau measure and area.
Stated Advantages
In the reported 25-patient cardiac-arrest cohort, secondary-peak area under the curve predicts six-month outcome with 100% sensitivity and 91% specificity.
Documented Applications
Determining a patient's prognosis of recovery from brain injury using tau measurements in serial blood, plasma, or serum samples.
Determining a method of treatment for a patient with brain injury based on the area under the curve of tau concentration measurements.
Assessing six-month outcome in the reported cardiac-arrest cohort.
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