JP-2022513721-A5 -

Dates

Publication Date

20221208

Application Date

20191203

Description

In some embodiments of the methods described above, the first biological sample and the second biological sample include blood, serum, plasma, or cerebrospinal fluid. The present invention provides, for example, the following items: (Item 1) A method for alleviating symptoms in a patient with amyotrophic lateral sclerosis, comprising administering an effective therapeutic agent to the patient, wherein the effective therapeutic agent, when administered to the patient, results in a level of neurofilament protein in a biological sample of the patient that is lower than the level of neurofilament protein in a patient with amyotrophic lateral sclerosis who has not been administered the effective therapeutic agent. (Item 2) A method for determining whether a therapeutic agent administered to a patient with amyotrophic lateral sclerosis is an effective therapeutic agent for the patient, comprising: obtaining or having obtained a biological sample from the patient who has been administered the therapeutic agent; and measuring or having measured the level of neurofilament protein in the patient's biological sample to obtain a post-treatment level, wherein the therapeutic agent is identified as effective for the patient by a post-treatment level lower than the level of neurofilament protein in a patient with amyotrophic lateral sclerosis who has not been administered the therapeutic agent. (Item 3) A method for alleviating the symptoms of patients with amyotrophic lateral sclerosis by administering an effective therapeutic agent, (a) (i) Obtaining or having obtained a biological sample from the patient after administration of the candidate therapeutic agent, and (ii) In order to obtain a post-treatment level, measure or have measured the level of neurofilament protein in the biological sample. This includes determining whether the symptoms of the patient's amyotrophic lateral sclerosis are alleviated by the candidate therapeutic agent, If the post-treatment level is lower than the neurofilament protein level of amyotrophic lateral sclerosis patients who have not been administered the candidate therapeutic agent, then the candidate therapeutic agent is an effective therapeutic agent. Furthermore, the above method, (b) Administer the effective therapeutic agent to the patient. Includes, The administration of the effective therapeutic agent alleviates the symptoms of amyotrophic lateral sclerosis in the patient. The aforementioned method. (Item 4) The method according to item 1, 2, or 3, wherein the patient is currently or has previously been administered (a) an ineffective therapeutic agent, or (b) a therapeutic agent different from the candidate therapeutic agent. (Item 5) A method for alleviating the symptoms of a patient with amyotrophic lateral sclerosis by administering an effective therapeutic agent, comprising measuring the level of neurofilament protein in a biological sample of the patient, wherein the patient is currently receiving a first therapeutic agent which is (a) an ineffective therapeutic agent or (b) a therapeutic agent different from the effective therapeutic agent, and the method further comprises discontinuing the administration of the first therapeutic agent to the patient and initiating the administration of the effective therapeutic agent to the patient if the level is equal to or greater than the level of neurofilament protein in a patient with amyotrophic lateral sclerosis who is not receiving the effective therapeutic agent. (Item 6) The method according to any one of items 1 to 5, wherein the post-treatment level of the neurofilament protein in the biological sample of the patient who has been administered the effective therapeutic agent is at least 10% lower than the level of the neurofilament protein in the biological sample of the patient who has not been administered the effective therapeutic agent. (Item 7) The method according to any one of items 1 to 5, wherein the post-treatment level of the neurofilament protein in the biological sample of the patient who has been administered the effective therapeutic agent for at least three months is at least 10% lower than the level of the neurofilament protein in the biological sample of the patient who has not been administered the effective therapeutic agent. (Item 8) The method according to any one of items 1 to 5, wherein the level of the neurofilament protein in the biological sample of the patient who has been administered the effective therapeutic agent for at least six months is at least 10% lower than the level of the neurofilament protein in the biological sample of the patient who has not been administered the effective therapeutic agent. (Item 9) The method according to any one of items 1 to 5, wherein the level of the neurofilament protein in the biological sample of the patient who has been administered the effective therapeutic agent for at least 12 months is at least 10% lower than the level of the neurofilament protein in the