Methods of determining response to therapy
AssigneeAlcobra Ltd.
InventorsYaron Daniely, Jonathan Rubin, Johanna Schumann
Life of this patent
Estimating the term…
Abstract
The present invention relates generally to methods of determining the response to metadoxine therapy for the treatment of Fragile X Syndrome and other cognitive disorders. The invention also relates to identifying individuals that will be responsive to metadoxine therapy.
Claims7
A method of assessing the effectiveness of a metadoxine treatment regimen in a subject having Fragile X Syndrome who has received metadoxine treatment, the method comprising:
- a) measuring the amount of phosphorylated ERK and Akt protein in a sample derived from the subject, wherein the sample is whole blood or a fraction thereof;
- b) measuring the total amount of ERK and Akt protein in the sample;
- c) calculating a ratio of the amount of phosphorylated ERK and Akt protein determined in step (a) to the amount of ERK and Akt protein determined in step b);
- and
- d) comparing the calculated ratio of step c) to a calculated ratio measured from a non-diseased subject, wherein when the calculated ratio of step c) is similar to the calculated ratio of the non-diseased subject, indicates that the treatment is effective.
A method of diagnosing a subject with Fragile X Syndrome as a responder to a metadoxine treatment regimen and treating Fragile X syndrome in the subject, the method comprising:
- a) measuring the amount of phosphorylated ERK and Akt protein in a sample derived from the subject, wherein the sample is whole blood or a fraction thereof;
- b) measuring the total amount of ERK and Akt protein in the sample;
- c) calculating a ratio of the amount of phosphorylated ERK and Akt protein determined in step (a) to the amount of ERK and Akt protein determined in step b);
- d) comparing the calculated ratio of step c) to a calculated ratio measured from a non-diseased subject and diagnosing the subject with Fragile X Syndrome as a responder to a metadoxine treatment regimen when the calculated ratio of step c) is higher than the calculated ratio of the non-diseased subject;
- and
- e) administering a metadoxine treatment regimen to the diagnosed subject.
A method of monitoring a metadoxine treatment regimen in a subject having Fragile X Syndrome, the method comprising:
- a) measuring the amount of phosphorylated ERK and Akt protein in a first sample from the subject at a first period of time, wherein the first sample is whole blood or a fraction thereof;
- b) measuring the total amount of ERK and Akt protein in the first sample at the first period of time;
- c) calculating a first ratio of the amount of phosphorylated ERK and Akt protein determined in step a) to the amount of total ERK and Akt protein determined in step b);
- d) measuring the amount of phosphorylated ERK and Akt protein in a second sample from the subject at a second period of time, wherein the second sample is whole blood or a fraction thereof;
- e) measuring the total amount of ERK and Akt protein in the second sample at the second period of time;
- f) calculating a second ratio of the amount of phosphorylated ERK and Akt protein determined in step d) to the total amount of ERK and Akt protein determined in step e) to produce a second ratio;
- g) comparing the first ratio to the second ratio.
Dependencies are inferred from the claim text.