TREATMENT OF NEURODEGENERATIVE DISEASE WITH SODIUM CHLORITE
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.
1 . A method of treating a childhood neurodegenerative disease comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable chlorite composition.
2 . The method of claim 1 , wherein said pharmaceutically acceptable chlorite composition comprises sodium chlorite.
3 . The method of claim 1 , wherein said pharmaceutical composition is suitable for parenteral administration or intravenous administration.
4 . The method of claim 1 , wherein said pharmaceutical composition is isotonic with a biological fluid of the subject.
5 . The method of claim 1 , wherein said pharmaceutical composition is administered by intravenous infusion over a period ranging from about 0.5 to about 4 hours.
6 . The method of claim 1 , wherein said pharmaceutical composition is administered at least once per month for a period of at least a year.
7 . The method of claim 1 , wherein said pharmaceutical composition is administered at least once per week for a period of at least one month.
8 . The method of claim 1 , wherein said pharmaceutically acceptable chlorite composition is administered in an amount ranging from 0.1 to 10 mg/kg body weight.
9 . The method of claim 8 , wherein said amount is about 1 to about 2 mg/kg body weight.
10 . The method of claim 1 , wherein said childhood neurodegenerative disease is Ataxia Telangiectasia (A-T).
11 . A method of treating frontotemporal dementia (FTD) comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable chlorite composition.
12 . The method of claim 11 , wherein said pharmaceutically acceptable chlorite composition is sodium chlorite.
13 . The method of claim 11 , wherein said pharmaceutical composition is suitable for parenteral administration or intravenous administration.
14 . The method of claim 11 , wherein said pharmaceutical composition is isotonic with a biological fluid of the subject.
15 . The method of claim 11 , wherein said pharmaceutical composition is administered by intravenous infusion over a period ranging from about 0.5 to about 4 hours.
16 . The method of claim 11 , wherein said pharmaceutical composition is administered at least once per month for a period of at least a year.
17 . The method of claim 11 , wherein said pharmaceutical composition is administered at least once per week for a period of at least one month.
18 . The method of claim 11 , wherein said pharmaceutically acceptable chlorite composition is administered in an amount ranging from 0.1 to 10 mg/kg body weight.
19 . The method of claim 11 , wherein said amount is about 1 to about 2 mg/kg body weight.
20 . The method of claim 11 , wherein said method reduces monocyte presence in the frontal and/or temporal lobes of a brain.
21 . The method of claim 11 , wherein said method reduces monocyte production of inflammatory proteins in the frontal and/or temporal lobes of the brain.
22 . The method of claim 11 , wherein said method reduces monocyte recruitment to the frontal and/or temporal lobes of the brain.
23 . The method of claim 11 , further comprising administering an antibiotic to the subject.
24 . The method of claim 23 , wherein the antibiotic is specific to a bacterial species present in the subject that is causing expression of an lipopolysaccharide binding protein to be significantly higher than a subject not harboring a bacterial species that causes elevated expression of the lipopolysaccharide binding protein.
25 . A method of treating Parkinson's disease comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable chlorite composition.
26 . The method of claim 25 , wherein said pharmaceutically acceptable chlorite composition is sodium chlorite.
27 . The method of claim 25 , wherein said pharmaceutical composition is suitable for parenteral administration or intravenous administration.
28 . The method of claim 25 , wherein said pharmaceutical composition is isotonic with a biological fluid of the subject.
29 . The method of claim 25 , wherein said pharmaceutical composition is administered by intravenous infusion over a period ranging from about 0.5 to about 4 hours.
30 . The method of claim 25 , wherein said pharmaceutical composition is administered at least once per month for a period of at least a year.
31 . The method of claim 25 , wherein said pharmaceutical composition is administered at least once per week for a period of at least one month.
32 . The method of claim 25 , wherein said pharmaceutically acceptable chlorite composition is administered in an amount ranging from 0.1 to 13.5 mg/kg body weight.
33 . The method of claim 32 , wherein said amount is about 1 to about 2 mg/kg body weight.
34 . The method of claim 25 , wherein said method reduces monocyte activation in the midbrain.
35 . The method of claim 25 , wherein said method reduces monocyte production of inflammatory proteins in the midbrain.
36 . The method of claim 25 , wherein said method reduces monocyte recruitment to the midbrain.
37 . A method of treating a subject for Duchenne's muscular dystrophy (DMD) comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable chlorite composition.
38 . The method of claim 37 , wherein said pharmaceutically acceptable chlorite composition is sodium chlorite.
39 . The method of claim 37 , wherein said pharmaceutical composition is suitable for parenteral administration or intravenous administration.
40 . The method of claim 37 , wherein said pharmaceutical composition is isotonic with a biological fluid of the subject.
41 . The method of claim 37 , wherein said pharmaceutical composition is administered by intravenous infusion over a period ranging from about 0.5 to about 4 hours.
42 . The method of claim 37 , wherein said pharmaceutical composition is administered at least once per month for a period of at least a year.
43 . The method of claim 37 , wherein said pharmaceutical composition is administered at least once per week for a period of at least one month.
44 . The method of claim 37 , wherein said pharmaceutically acceptable chlorite composition is administered in an amount ranging from 0.1 to 10 mg/kg body weight.
45 . The method of claim 44 , wherein said amount is about 1 to about 2 mg/kg body weight.
46 . A method of preventing or delaying an onset of a symptom of a neurodegenerative disease, comprising administering a chlorite composition to a subject in need thereof,
wherein the subject harbors a mutation in a gene, wherein the mutation in the gene is associated with the neurodegenerative disease; and
wherein a level of a marker of the neurodegenerative disease is altered in a biological sample of the subject relative to a level of the marker in a control biological sample of a control subject.
47 . The method of claim 46 , comprising detecting the mutation in the biological sample of the subject.
48 . The method of claim 46 , comprising detecting the marker in the biological sample.
49 . The method of claim 46 , comprising quantifying the marker in the biological sample.
50 . The method of claim 49 , wherein the level of the marker is at least 30% different than the level of the marker in the control sample of the control subject.
51 . The method of claim 50 , wherein the level of the marker is at least 50% different than the level of the marker in the control sample of the control subject.
52 . The method of claim 46 , wherein the biological sample is selected from a whole blood sample, a plasma sample, a serum sample, a urine sample, and a cerebrospinal fluid sample.
53 . The method of claim 46 , wherein the neurodegenerative disease is selected from frontotemporal dementia, amyotrophic lateral sclerosis, or a condition in the spectrum thereof.
54 . The method of claim 46 , wherein the neurodegenerative disease is Frontotemporal Dementia, Amyotrophic Lateral Sclerosis or a combination thereof, and the gene is selected from c9orf72, microtubule associated protein tau, transactive response DNA binding protein 43 kDa, valosin containing protein, charged multivesicular body protein 2B, superoxide dismutase 1 gene, fused in sarcoma gene, and progranulin, and combinations thereof.
55 . The method of claim 54 , wherein the marker is an inflammatory factor.
56 . The method of claim 54 , wherein the marker is selected from CCL18, LBP, CD163, and CRP.
57 . The method of claim 54 , wherein the marker is selected from CRP and CD163.
58 . The method of claim 46 , wherein the neurodegenerative disease is Ataxia Telangiectasia (A-T), the gene is an Ataxia Telangiectasia Mutated gene, and the marker is selected from, CD14, HLA-DR, CD14, CD16, CD4, CD38, CD8, CD38, soluble CD14, soluble CD163, monocyte chemoattractant 1, Osteopontin, C-reactive protein, and interleukin-8.
59 . The method of claim 46 , wherein the neurodegenerative disease is Parkinson's Disease, and the gene is selected from alpha-synuclein, parkin, leucine-rich repeat kinase 2, PTEN-induced putative kinase 1, protein deglycase, and ATPase 13A2, and combinations thereof.
60 . The method of claim 46 , wherein the neurodegenerative disease is Duchenne's Muscular Dystrophy, and the gene is dystrophin.
61 . The method of claim 46 , wherein the subject has not displayed a symptom of the neurodegenerative disease before administering the chlorite composition.
62 . The method of claim 46 , wherein the subject has not displayed a physical symptom of the neurodegenerative disease before administering.
63 . The method of claim 46 , wherein the subject has not displayed a behavioral symptom of the neurodegenerative disease before administering.
64 . The method of claim 46 , wherein said chlorite composition is administered by intravenous infusion over a period ranging from about 0.5 to about 4 hours.
65 . The method of claim 46 , wherein said chlorite composition is administered at least once per month for a period of at least a year.
66 . The method of claim 46 , wherein said chlorite composition is administered at least once per week for a period of at least one month.
67 . The method of claim 46 , wherein said chlorite composition is administered in an amount ranging from 0.1 to 10 mg/kg body weight.
68 . The method of claim 67 , wherein said amount is about 1 to about 2 mg/kg body weight.