Prevention or Treatment of Disease States Due to Metal Dis-Homeostasis Via Administration of Posiphen to Healthy or Sick Humans

Abstract

The invention relates in part to a method of maintaining heavy metal homeostasis in healthy humans, comprising chronically administering to healthy humans a pharmaceutical composition consisting of from about 1 mg to less than about 200 mg of Posiphen or a pharmaceutically acceptable salt thereof together with one or more pharmaceutically acceptable excipients, on a once a day basis. By virtue of this method, prophylactic treatment of a potential disease state such as a neurodegenerative disease, cardiovascular homeostasis, cancer, vital organ homeostasis, and the like. The invention also relates in part to a method of restoring heavy metal homeostasis in sick patients, comprising chronically administering to a sick patient a pharmaceutical composition consisting of from about 1 mg to less than about 200 mg of Posiphen or a pharmaceutically acceptable salt thereof together with one or more pharmaceutically acceptable excipients, on a once a day basis. By virtue of this method, treatment of a potential disease state such as a neurodegenerative disease, cardiovascular disease, cancer, vital organ dysfunction and heavy metal dis-homeostasis, and the like.

What is claimed is: 
     
         1 . A method of maintaining heavy metal homeostasis in a healthy human or restoring heavy metal homeostasis in a sick human patient, comprising chronically administering a pharmaceutical composition comprising an active agent selected from the group consisting of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof, together with one or more pharmaceutically acceptable excipients in a therapeutically effective amount to maintain heavy metal homeostasis in the healthy human patient or restore heavy metal homeostasis in the sick human patient. 
     
     
         2 . The method of  claim 1 , wherein the metal is iron. 
     
     
         3 . The method of  claim 1 , wherein Posiphen is administered in an amount from about 1 mg to less than about 200 mg. 
     
     
         4 . The method of  claim 3 , wherein Posiphen is administered orally on a once a day basis. 
     
     
         5 . The method of  claim 1 , wherein Posiphen is administered in an amount from about 1 mg to about 30 mg, per day. 
     
     
         6 . The method of  claim 5 , wherein Posiphen is administered orally. 
     
     
         7 . The method of  claim 1 , wherein the patient is a healthy human, and the chronic administration maintains heavy metal homeostasis in the healthy human. 
     
     
         8 . The method of  claim 1 , wherein the patient is a sick patient and the chronic administration restores heavy metal homeostasis in the sick human patient. 
     
     
         9 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof prevents, stops, slows or delays the onset of a neurodegenerative disease or condition in a healthy human. 
     
     
         10 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof prevents, stops, slows or delays the course of a neurodegenerative disease or condition in a sick human patient suffering from a neurodegenerative disease. 
     
     
         11 . The method of  claim 10 , wherein the neurodegenerative disease is selected from the group consisting of Alzheimer's disease, Down Syndrome, alpha-synucleopathies, Parkinson's disease, Huntington's disease, Prion's disease, Amyloid Lateral Sclerosis, Multiple Sclerosis, Tauopathies and other chronic and acute neurodegenerative disorders. 
     
     
         12 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof prevents, stops, slows or delays the onset of cancer in a healthy human. 
     
     
         13 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof prevents, stops, slows or delays the course of cancer in a sick human patient suffering from cancer. 
     
     
         14 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof prevents, stops, slows or delays the onset of cardiovascular disease in a healthy human. 
     
     
         15 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof prevents, stops, slows or delays the course of cardiovascular disease in a sick human patient. 
     
     
         16 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof maintains homeostasis in vital organs in a healthy human. 
     
     
         17 . The method of any of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof restores homeostasis in vital organs in a sick human patient. 
     
     
         18 . The method of  claim 17 , wherein the vital organ is selected from, e.g., brain, heart, lung, liver, and/or kidney. 
     
     
         19 . The method of  claim 1 , wherein the administration of Posiphen, a therapeutically effective amount of Posiphen, active metabolites of Posiphen, therapeutically effective analogues of Posiphen, and pharmaceutically acceptable salts and complexes thereof restores homeostasis in a human who has suffered an acute injury/incidence, including but not limited to traumatic brain injury, spinal cord injury, stroke, heart attack, acute glaucoma, near drowning, etc. in which the methods of the invention will further comprise or consist of chronically administering to the patient who has suffered an acute injury/incidence such that there is stasis or amelioration of symptoms or effects of the acute injury/incidence. 
     
     
         20 . The method of  claim 1 , wherein Posiphen is chronically administered and Posiphen is administered via a route selected from the group consisting of orally, parenterally, sublingually, via suppository, nasally, topically, transdermally, and via implant under the skin.