# US 12,109,231 B2 · Treatment of neurodegenerative disease with sodium chlorite > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,231 B2 - Document ID: US12109231B2 - Status: Granted - Kind: B2 - Application number: 18/441,621 - Filed: 2024-02-14 - Published: 2024-08-08 - Granted: 2024-10-08 - Earliest claimed: 2015-11-02 - Assignees: Neuvivo, Inc.; The Regents of the University of California - Applicants: Neuvivo, Inc.; The Regents of the University of California - Inventors: Vernon A. Norviel; Michael S. McGrath - Web page: https://patentgrep.com/patent/US12109231B2 ## CPC - A61K 33/20: Elemental chlorine; Inorganic compounds releasing chlorine - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention provides a method of treating frontotemporal dementia, or a childhood genetic neurodegenerative disease such as Ataxia Telangiectasia (A-T), or neurodegenerative diseases such as Parkinson's disease or neuropsychiatric diseases comprising administering to a subject in need thereof an effective amount of chlorite composition, such as sodium chlorite. The present invention thereby provides a method of modulating the immune system in a subject in need thereof. Described herein are methods of administration and treatment. ## Claims ### Claim 1 A method comprising: a) administering to a subject who has Amyotrophic Lateral Sclerosis (ALS) a regimen of sodium chlorite; and b) monitoring a plasma level of C-reactive protein in the subject during the regimen of sodium chlorite and determining based on the monitoring that the plasma level of C-reactive protein in the subject is at least 1125 ng/mL, wherein the subject is human; wherein the subject exhibits a symptom of Amyotrophic Lateral Sclerosis (ALS); wherein the sodium chlorite is administered in an amount ranging from 0.1 to 10 mg/kg by body weight of the subject; wherein the administering occurs at least once per month for a period of at least a year; and wherein the administering occurs over a period ranging from about 0.5 to about 4 hours. ### Claim 2 (depends on 1) The method of claim 1, wherein the administering is parenteral. ### Claim 3 (depends on 1) The method of claim 1, wherein the administering is intravenous. ### Claim 4 (depends on 1) The method of claim 1, wherein the sodium chlorite is administered in an amount ranging from 1 to 2 mg/kg by body weight. ### Claim 5 (depends on 1) The method of claim 1, wherein the monitoring the plasma level of C-reactive protein in the subject during the regimen of sodium chlorite comprises detecting the C-reactive protein in a biological sample of the subject. ### Claim 6 (depends on 1) The method of claim 1, wherein the monitoring the plasma level of C-reactive protein in the subject during the regimen of sodium chlorite comprises quantifying the C-reactive protein in a biological sample of the subject. ### Claim 7 (depends on 1) The method of claim 1, wherein the administering of the sodium chlorite is by administration of a formulation, wherein the formulation comprises: a) the sodium chlorite; b) phosphate buffer; c) chloride ions in an amount of less than about 1% of chlorite ions in the formulation; and d) chlorate ions in an amount of less than about 1.5% of chlorite ions in the formulation, wherein the formulation has a pH of about 7 to about 11. ### Claim 8 (depends on 7) The method of claim 7, wherein the chloride ions are in an amount from about 0.1% to about 0.5% of chlorite ions in the formulation; the chlorate ions are in an amount from about 0.1% to about 0.5% of chlorite ions in the formulation; and the pH is about 7 to about 9.5. ### Claim 9 (depends on 7) The method of claim 7, wherein the chloride ions are in an amount of less than about 0.1% of chlorite ions in the formulation; the chlorate ions are in an amount from about 0.001% to about 0.1% of chlorite ions in the formulation; and the pH is about 7.5 to about 9. ### Claim 10 (depends on 1) The method of claim 1, wherein the symptom of Amyotrophic Lateral Sclerosis (ALS) is a behavioral symptom of Amyotrophic Lateral Sclerosis (ALS). ### Claim 11 (depends on 1) The method of claim 1, wherein the symptom of Amyotrophic Lateral Sclerosis (ALS) is a physical symptom of Amyotrophic Lateral Sclerosis (ALS). ### Claim 12 A method comprising: a) administering to a subject who has Amyotrophic Lateral Sclerosis (ALS) a regimen of sodium chlorite; and b) monitoring a plasma level of C-reactive protein in the subject during the regimen of sodium chlorite and determining based on the monitoring that the plasma level of C-reactive protein in the subject is at least 1125 ng/mL, wherein the subject is human; wherein the subject exhibits a behavioral symptom of Amyotrophic Lateral Sclerosis (ALS); wherein the subject exhibits a physical symptom of Amyotrophic Lateral Sclerosis (ALS); wherein the sodium chlorite is administered in an amount ranging from 1 to 2 mg/kg by body weight of the subject; wherein the administering occurs at least once per month for a period of at least a year; wherein the administering occurs over a period ranging from about 0.5 to about 4 hours; wherein the administering is parenteral; and wherein the administering of the sodium chlorite is by administration of a formulation, wherein the formulation comprises: a) the sodium chlorite; b) phosphate buffer; c) chloride ions in an amount of less than about 1% of chlorite ions in the formulation; and d) chlorate ions in an amount of less than about 1.5% of chlorite ions in the formulation, wherein the formulation has a pH of about 7 to about 11. ### Claim 13 (depends on 12) The method of claim 12, wherein the administering is intravenous. ### Claim 14 (depends on 12) The method of claim 12, wherein the monitoring the plasma level of C-reactive protein in the subject during the regimen of sodium chlorite comprises detecting the C-reactive protein in a biological sample of the subject. ### Claim 15 (depends on 12) The method of claim 12, wherein the monitoring the plasma level of C-reactive protein in the subject during the regimen of sodium chlorite comprises quantifying the C-reactive protein in a biological sample of the subject. ### Claim 16 (depends on 12) The method of claim 12, wherein the chloride ions are in an amount from about 0.1% to about 0.5% of chlorite ions in the formulation; the chlorate ions are in an amount from about 0.1% to about 0.5% of chlorite ions in the formulation; and the pH is about 7 to about 9.5. ### Claim 17 (depends on 12) The method of claim 12, wherein the chloride ions are in an amount of less than about 0.1% of chlorite ions in the formulation; the chlorate ions are in an amount from about 0.001% to about 0.1% of chlorite ions in the formulation; and the pH is about 7.5 to about 9. ### Claim 18 A method comprising: a) administering to a subject who has Amyotrophic Lateral Sclerosis (ALS) a regimen of sodium chlorite; and b) monitoring a plasma level of C-reactive protein in the subject during the regimen of sodium chlorite and determining based on the monitoring that the plasma level of C-reactive protein in the subject is at least 1125 ng/mL, wherein the subject is human; wherein the subject exhibits a speech disorder; wherein the subject exhibits poor coordination; wherein the subject exhibits progressive muscle weakness; wherein the subject exhibits progressive muscle wasting; wherein the subject exhibits respiratory failure; wherein the sodium chlorite is administered in an amount ranging from 1 to 2 mg/kg by body weight of the subject; wherein the administering occurs at least once per month for a period of at least a year; wherein the administering occurs over a period ranging from about 0.5 to about 4 hours; wherein the administering is intravenous; and wherein the administering of the sodium chlorite is by administration of a formulation, wherein the formulation comprises: a) the sodium chlorite; b) phosphate buffer; c) chloride ions in an amount from about 0.1% to about 0.5% of chlorite ions in the formulation; and d) chlorate ions in an amount from about 0.1% to about 0.5% of chlorite ions in the formulation, wherein the formulation has a pH of about 7 to about 9.5. ### Claim 19 (depends on 18) The method of claim 18, wherein the chloride ions are in an amount of less than about 0.1% of chlorite ions in the formulation; the chlorate ions are in an amount from about 0.001% to about 0.1% of chlorite ions in the formulation; and the pH is about 7.5 to about 9. ### Claim 20 (depends on 18) The method of claim 18, wherein the monitoring the plasma level of C-reactive protein in the subject during the regimen of sodium chlorite comprises detecting and quantifying the C-reactive protein in a biological sample of the subject.