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OwnerSimona Piccirella, Daniela Letizia Ubertiinventors
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The present invention refers to p53 sequence and post translational modifications (PTMs) and to their use as biomarkers in the diagnosis of neurodegenerative disease and cognitive decline and/or in the prognosis of Alzheimer's disease at different stages and/or of neurodegenerative disease in a biological sample. The invention also provides for a 1) diagnostic method based on a highly accurate mass spectrometry analysis for the diagnosis of neurodegenerative disease, including Mild Cognitive Impairment (MCI), Alzheimer's disease (AD), fronto-temporal dementia (FTD), Lewi's Body (LB), and vascular dementia (VD) in a subject, by evaluating the PTMs to the said p53 linear sequence protein and possible cut of its full sequence specifically in human plasma of patients; and 2) prognosis of AD in CU and MCI patients.
An in vitro or ex vivo method to differentiate Alzheimer's Disease (AD) from Cognitive Unimpaired (CU) in a subject, the method comprising detecting in a biofluid sample of said subject the presence and/or absence of one or more post-translation modifications (PTMs) in the region of amino acids 1-371 of the p53 protein (U-p53), said PTMs comprising PTMs-1-12,
An in vitro or ex vivo method to differentiate Alzheimer's Disease (AD) and a neurodegenerative disease selected from the following:
An in vitro or ex vivo method to differentiate Cognitive Unimpaired (CU) and a neurodegenerative disease selected from the following:
An in vitro or ex vivo method to differentiate Mild Cognitive Impairment (MCI) from a neurodegenerative disease selected from the following:, MCI with a prognosis of cognitive decline of AD (MCI to AD), cognitive decline of an asymptomatic subject to AD (CU to AD), Alzheimer's disease (AD), Frontotemporal dementia (FTD), Lewi's body dementia (LB) and Vascular dementia (VD) in a subject, the method comprising detecting in a biofluid sample of said subject the presence and/or absence of one or more post-translation modifications (PTMs) in the region of amino acids 1-371 of the p53 protein (U-p53), said PTMs comprising PTMs-1-12, wherein MCI is differentiated from a said neurodegenerative disease as follows (A)-(F):
An in vitro or ex vivo method to differentiate cognitive decline of an asymptomatic subject to AD (CU to AD) from a neurodegenerative disease selected from the following:, MCI with a prognosis of cognitive decline of AD (MCI to AD), Alzheimer's disease (AD), Frontotemporal dementia (FTD), Lewi's body (LB) and Vascular dementia (VD) in a subject, the method comprising detecting in a biofluid sample of said subject the presence and/or absence of one or more post-translation modifications (PTMs) in the region of amino acids 1-371 of the p53 protein (U-p53), said PTMs comprising PTMs-1-12, wherein CU is differentiated from a said neurodegenerative disease as follows (A)-(E):
An in vitro or ex vivo method to differentiate Mild Cognitive Impairment with a prognosis of cognitive decline of AD (MCI progression to AD) from a neurodegenerative disease selected from the following:, cognitive decline of an asymptomatic subject to AD (CU progression to AD), Alzheimer's disease (AD), Frontotemporal dementia (FTD), Lewi's body (LB) and Vascular dementia (VD) in a subject, the method comprising detecting in a biofluid sample of said subject the presence and/or absence of one or more post-translation modifications (PTMs) in the region of amino acids 1-371 of the p53 protein (U-p53), said PTMs comprising PTMs-1-12, wherein MCI is differentiated from a said neurodegenerative disease as follows (A)-(E):
An in vitro or ex vivo method to differentiate Frontotemporal dementia (FTD) from a neurodegenerative disease selected from Lewi's body (LB) and Vascular dementia (VD) in a subject, the method comprising detecting in a biofluid sample of said subject the presence and/or absence of one or more post-translation modifications (PTMs) in the region of amino acids 1-371 of the p53 protein (SEQ ID NO:1), said PTMs comprising PTMs-1-12, wherein FTD is differentiated from LB and from VD as follows (A) and (B), respectively:
An in vitro or ex vivo method to differentiate Lewi's body dementia (LB) and Vascular dementia (VD) in a subject, the method comprising detecting in a biofluid sample of said subject the presence and/or absence of one or more post-translation modifications (PTMs) in the region of amino acids 1-371 of the p53 protein (SEQ ID NO:1), said PTMs comprising PTMs-1-12,
An in vitro or ex vivo method to identify in a subject a neurodegenerative disease selected from:
An in vitro or ex vivo method for the diagnosis or prognosis of a neurodegenerative disease, the method comprising the step of:
The in vitro or ex vivo method of claim 24, wherein the biological sample of step a) is subjected to protein plasma depletion by HPLC or chromatographic columns or chemical treatment, before performing the step (ii).
Dependencies are inferred from the claim text.