Estriol Therapy for Autoimmune and Neurodegenerative Diseases and Disorders

• US 20090131385A1
• Filed: 09/26/2006
• Published: 05/21/2009
• Est. Priority Date: 04/25/2001
• Status: Abandoned Application

• Current Assignee: Rhonda Voskuhl
• Original Assignee: Rhonda Voskuhl
• Inventors: Voskuhl, Rhonda
• Application Number:
  US11/992,559
• Publication Number:
  US 20090131385A1
• Time in Patent Office: Days
• US Class Current: 514/178
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: 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

Abstract

The present invention discloses administering steroid hormones to mammals to treat autoimmune related diseases, neurodegenerative diseases or disorders, such as Alzheimer'"'"'s disease, Parkinson'"'"'s Disease, multiple sclerosis, stroke, ALS Pick'"'"'s disease, prion disease and Huntington'"'"'s disease. Most preferably the invention uses estrogens, estranges, estriol or estrogen receptor active agents to prevent or ameliorate clinical symptoms of the diseases and disorders.

Claims

1. A method of treating a patient exhibiting at least on clinical symptom of a neurodegenerative disease comprising administering at least one primary agent being an estrogen or estrogen receptor active agent at a therapeutically effective dosage in an effective dosage form to a patient in order to prevent or treat a neurodegenerative disease.

2. The method of claim 1 wherein the neurodegenerative disease is selected from the group comprising:

Alzheimer'"'"'s disease, Parkinson'"'"'s disease, multiple sclerosis, stroke, amyotrophic lateral sclerosis, frontotemporal dementia, prion disease, Huntington'"'"'s Disease.

3. The method of claim 1 wherein the neurodegenerative disease is selected from the group including cerebral ischaemia, idiopathic Morbus Parkinson, Parkinson syndrome, Morbus Alzheimers, cerebral dementia syndrome, infectious-induced neurodegeneration disorders metabolic-toxic neurodegenerative disorders, encephalopathies induced by solvents or pharmaceuticals, degenerative retina disorders, traumatically-induced brain damage, traumatically-induced bone marrow damage, cerebral hyperexcitability symptoms, cerebral hyperexcitability states, neurodegenerative syndromes of the peripheral nervous system, peripheral nerve injury, and spinal cord injury.

4. The method of claim 1 wherein the primary agent is selected from the group of estriol, estrone, 17.beta.-estradiol, aromatizable testosterone, estrogen receptor alpha agonists, and estrogen receptor beta agonists.

5. The method of claim 1 wherein the estriol is nyestriol, estriol succinate or estriol sulfamate or estriol dihexanate.

6. The method of claim 1 wherein the primary agent is estriol and the therapeutically effective dosage is about 0.001 to about 16 milligrams each 24 hours.

7. The method of claim 1 wherein the primary agent is estriol and the therapeutically effective dosage is about 8 milligrams each 24 hours.

8. The method of claim 1 wherein the primary agent is estriol and treatment results in patient serum concentrations of estriol of about 2 to about 30 nanograms per milliliter.

9. The method of claim 1 wherein the primary agent is estradiol and treatment results in patient serum concentrations of estradiol of about 2 to about 35 nanograms per milliliter.

10. The method of claim 1 wherein the primary agent is estrone and treatment results in patient serum concentrations of estrone of about 2 to about 18 nanograms per milliliter.

11. The method of claim 1 wherein the treatment results in serum levels of estrogen are equivalent to those of a women in the mid second trimester through the end of the third trimester of pregnancy.

12. The method of claim 1, further comprising administering at least one secondary agent at a therapeutically effective dosage in an effective dosage form at a selected interval concurrently with the primary agent.

14. The method of claim 1, further comprising administering at least one secondary agent at a therapeutically effective dosage in an effective dosage form at a selected interval.

13. A method of preventing or treating a patient exhibiting at least one clinical symptom of a neurodegenerative disease or disorder comprising administering 8 milligrams of estriol orally each 24 hours to ameliorate the symptoms of the disease or disorder.

15. The method of claim 13, wherein the method further comprises treating the patient with a secondary agent.

16. The method of claim 15, wherein the secondary agent is progesterone at a dose of about 100 to about 200 milligrams daily.

17. The method of claim 15, wherein the secondary agent is norethindrone at a dose of about 0.35 milligrams daily.

21. The method of claim 17, wherein the neurodegenerative disease is multiple sclerosis and the treatment with estrogen receptor beta ligand results in at least one of reduced demyelination, reduces axon loss, reduces neuronal abnormalities and reduced motor impairment, reduced relapses.

23. The method of claim 17, further comprising administering at least one secondary agent at a therapeutically effective dosage in an effective dosage form at a selected interval.

18. A method of treating a patient exhibiting at least one symptom of a neurodegenerative disease or disorder to ameliorate at least on symptom of that disease or disorder comprising administering estriol at a dose of about 4 to about 16 milligrams of estriol each 24 hours;

and progesterone at a dose of about 100 to about 200 milligrams per 24 hours.

22. The method of claim 18, wherein the patient is diagnosed as being in the post-acute phase of multiple sclerosis.

19. A method of treating a patient exhibiting at least one clinical symptoms of neurodegeneration to ameliorate the disease comprising administering estriol at a dose of about 4 to about 16 milligrams of estriol each 24 hours;

and a glucocorticoid.

20. A method of treating a patient to prevent or ameliorate the symptoms of the neurodegenerative disease or disorder comprising administering an estrogen receptor beta agonist at a therapeutically effective dosage in an effective dosage form.