Method for predicting whether subjects with mild cognitive impairment (MCI) will develop Alzheimer's Disease
AssigneeMolecular Geriatrics Corporation
InventorsDaniel Kerkman, John F. DeBernardis, Raymond Zinkowski, Harald Juergen Hampel
Life of this patent
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Abstract
The invention provides methods of diagnosing mild cognitive impairment (MCI) in a patient and methods of predicting cognitive decline in patients who have MCI. The invention also provides methods for predicting if a patient who has MCI will develop Alzheimer's Disease (AD).
Claims49
A method of predicting whether a patient will develop Alzheimer's Disease comprising:
- a) determining the level of phosphorylated tau protein (p-tau) in a sample of cerebrospinal fluid (CSF) taken from the patient;
- b) determining the CSF level of p-tau obtained from at least one control patient;
- c) comparing the CSF level of p-tau from the patient with the CSF level of p-tau obtained from the at least one control patient, wherein the greater the difference between the CSF level of p-tau from the patient and the CSF level of p-tau from the control patient, the greater the risk of developing AD.
A method of diagnosing a patient who is likely to develop Alzheimer's Disease (AD) comprising measuring the level of p-tau in the CSF of a patient, wherein a CSF p-tau level of at least about 215 pg/ml in the patient is indicative of a patient who is likely to convert to AD.
A method of diagnosing a patient as having mild cognitive impairment (MCI) comprising:
- a) determining the level of phosphorylated tau protein in a sample of cerebrospinal fluid (CSF) taken from the patient;
- b) determining the CSF level of p-tau obtained from at least one control patient;
- c) comparing the CSF level of p-tau from the patient with the CSF level of p-tau obtained from the at least one control patient, wherein the patient is diagnosed as having MCI if the CSF level of p-tau is greater in the patient than in the at least one control patient.
A method of predicting the rate of neuronal degeneration in a patient comprising determining the level of phosphorylated tau protein in a sample of cerebrospinal fluid (CSF) taken from the patient, wherein the patient has Alzheimer's Disease.
A method of identifying a patient who is likely to develop Alzheimer's Disease comprising:
- a) obtaining a biological sample from a patient;
- b) determining the level of phosphorylated tau protein (p-tau) in the biological sample;
- c) identifying the patient as being likely to develop Alzheimer's Disease if the level of p-tau in the biological sample is about 617 pg/ml or higher.
A method of predicting cognitive decline in a patient, comprising the steps of:
- a) obtaining a biological sample from a patient;
- b) determining the level of phosphorylated tau protein (p-tau) in the biological sample;
- c) identifying the patient as being likely to cognitively decline if the level of p-tau in the biological sample is about 143 pg/ml or higher.
A method of diagnosing Alzheimer's Disease in a patient, comprising the steps of:
- a) obtaining a biological sample from a patient;
- b) determining the level of p-tau protein in the biological sample;
- and
- c) diagnosing the patient as having Alzheimer's Disease if the level of p-tau in the biological sample is about 215 pg/ml or higher.
A method of monitoring cognitive decline in a patient comprising the steps of:
- a) determining the level of p-tau protein in a biological sample obtained from the patient;
- b) determining the p-tau load in the sample by adjusting the p-tau level using a ventricular volume correction;
- c) repeating steps (a) and (b) using a subsequently-collected biological sample obtained from the patient;
- and
- d) comparing the p-tau load determined in step (b) with the amount of the p-tau load determined in step (c) and therefrom monitoring cognitive decline in the patient.
A method of measuring the effectiveness of a pharmaceutical composition as an agent for treating a patient having a condition associated with dementia, comprising the steps of:
- a) determining the level of p-tau protein in a biological sample obtained from the a patient;
- b) administering an amount of a pharmaceutical composition to the patient;
- c) repeating step (a) using a subsequently-collected biological sample obtained from the patient;
- d) comparing the level of p-tau protein determined in step (a) with the level of p-tau protein determined in step (c), wherein the effectiveness of the pharmaceutical composition is monitored by detecting no change in the level or p-tau or a decrease in the level of p-tau in the subsequently-collected biological sample compared with the biological sample from step (a).
A method of predicting a rate of neuronal degeneration in a patient comprising determining the level of phosphorylated tau (p-tau) protein in a sample of cerebrospinal fluid (CSF) taken from the patient, wherein the patient has Alzheimer's Disease.
Dependencies are inferred from the claim text.