Use of ventricular enlargement rate in intravenous immunoglobulin treatment of alzheimers disease
AssigneesBaxter Healthcare S.A., Baxter International Inc.
InventorNorman R. Relkin
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Abstract
The present invention relates to the use of MRI monitoring of ventricular enlargement rate as an objective measure for the purpose of assessing disease progression in patients suffering from Alzheimer's disease and for the purpose of determining therapeutic effectiveness of a treatment regimen for Alzheimer's patients. Methods for treating Alzheimer's Disease and monitoring therapeutic effectiveness are provided.
Claims17
A method for treating Alzheimer's disease in a subject in need thereof, comprising the sequential steps of:
- (a) determining ventricular volume in the subject's brain by magnetic resonance imaging (MRI), thereby obtaining a baseline value of ventricular volume;
- (b) administering a brain preserving therapeutic agent to the subject for the purpose of treating Alzheimer's disease during a first time period;
- (c) determining ventricular volume in the subject's brain by MRI, thereby obtaining a first intermediate value of ventricular volume;
- (d) comparing the intermediate value from step (c) with the baseline value from step (a);
- and
- (e) increasing administration of the brain preserving therapeutic agent in dose or frequency when step (d) indicates an increase from the baseline value to the first intermediate value and the increase is equal to or greater than an expected increase in ventricular volume in a subject with Alzheimer's disease but without receiving treatment for the disease within a time period of the same duration as the first time period, or
- maintaining administration of the brain preserving therapeutic agent in dose or frequency when step (d) indicates no increase from the baseline value to the first intermediate value or indicates an increase that is less than an expected increase in ventricular volume in a subject with Alzheimer's disease but without receiving treatment for the disease within a time period of the same duration as the first time period.
A method for assessing efficacy of a therapy intended for treating Alzheimer's disease, comprising the steps of:
- (a) determining the rate of change in ventricular volume of subjects suffering from Alzheimer's disease but not receiving the therapy, thereby obtaining an average rate of change in ventricular volume as a non-therapeutic rate of ventricular volume change;
- (b) determining the rate of change in ventricular volume of subjects suffering from Alzheimer's disease and receiving the therapy, thereby obtaining an average rate of change in ventricular volume as a therapeutic rate of ventricular volume change;
- and
- (c) comparing the therapeutic rate with the non-therapeutic rate, thereby determining the efficacy of the therapy,
- wherein the ventricular volume in steps (a) and (b) is determined by magnetic resonance imaging (MRI), and wherein the therapy is deemed effective when the therapeutic rate is lower than the non-therapeutic rate, and the therapy is deemed ineffective when the therapeutic rate is equal to or greater than the non-therapeutic rate.
Dependencies are inferred from the claim text.