Neurofilament protein for guiding therapeutic intervention in amyotrophic lateral sclerosis

A method for alleviating a symptom in a patient with amyotrophic lateral sclerosis by administration of an efficacious therapeutic, comprising:

• (a) determining whether a symptom of amyotrophic lateral sclerosis in the patient will be alleviated by a candidate therapeutic by:
• (i) obtaining or having obtained a biological sample from the patient following administration of the candidate therapeutic;
• and
• (ii) measuring or having measured a level of a neurofilament protein in the biological sample to obtain a post-treatment level;
• and if the post-treatment level is lower than a level of neurofilament protein in a patient with amyotrophic lateral sclerosis not administered the candidate therapeutic, then the candidate therapeutic is an efficacious therapeutic and
• (b) administering the efficacious therapeutic to the patient, wherein administration of the efficacious therapeutic will alleviate the symptom of amyotrophic lateral sclerosis in the patient.

A method of treating amyotrophic lateral sclerosis in a human subject in need thereof, comprising:

• measuring a neurofilament protein level in a first biological sample obtained from the human subject;
• administering one or more doses of a therapeutic to the human subject;
• and
• measuring a neurofilament protein level in a second biological sample obtained from the human subject after administering the one or more doses of the therapeutic, wherein the neurofilament protein level in the second biological sample is lower than the neurofilament protein level in the first biological sample.

A method of treating amyotrophic lateral sclerosis in a human subject in need thereof, comprising:

• administering initial doses of a therapeutic to the human subject, wherein each of the initial doses is in the same amount and is administered at the same dosing interval between doses;
• measuring a neurofilament protein level in a first biological sample obtained from the human subject after administering the initial doses that is lower than a neurofilament protein level measured in a second biological sample obtained from the human subject prior to administering the initial doses;
• and
• administering further doses of the therapeutic to the human subject, wherein each of the further doses is in the same or lesser amount and at the same or lengthened dosing interval as compared to the initial doses.

A method of treating amyotrophic lateral sclerosis in a human subject in need thereof, comprising:

• administering initial doses of a therapeutic to the human subject, wherein each of the initial doses is in the same amount and is administered at the same dosing interval between doses;
• measuring a neurofilament protein level in a first biological sample obtained from the human subject after administering the initial doses that is equal to or higher than a neurofilament protein level measured in a second biological sample obtained from the human subject prior to administering the initial doses;
• and
• administering further doses of the therapeutic to the human subject, wherein each of the further doses is in an increased amount and/or at a shortened dosing interval as compared to the initial doses.