Ultra-low dose thc as a potential therapeutic and prophylactic agent for alzheimer's disease

Abstract

Alzheimer's disease is treated using THC (alone, or in combination with melatonin) administered in an ultra-low dose amount sufficient to (i)reduce Aβ expression; (ii) reduce Aβ aggregation: (iii) maintain APP expression; (iv) enhance mitochondrial functioning; (v) decrease phosphorylation of GSK3β protein; (vi) decrease the expression of GSK3β protein; (vii) decrease phosphorylation of Tau protein; and/or (viii) maintain Tau protein expression, in said patient without severe psychological impairments and side effects associated with higher doses of THC.

What is claimed is: 
     
         1 . A composition for maintaining amyloid precursor protein level in a patient suffering from Alzheimer's disease, the composition comprising:
 a. tetrahydrocannabinol (THC) in an ultra-low dose amount of about 0.2 μg/kg to about 0.02 mg/kg of body weight of the patient; and   b. melatonin in an amount from about 0.11 mg/kg to about 1.1 mg/kg of body weight of the patient, wherein Aβ production and aggregation is concurrently decreased.   
     
     
         2 . The composition of  claim 1 , wherein the THC is selected from the group consisting of organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A. 
     
     
         3 . A composition for treating Alzheimer's disease comprising tetrahydrocannabinol (THC) and melatonin wherein THC is an ultra-low dose amount from about 14 μg to about 2.0 mg per 70 kg patient and melatonin is in a dose amount of from about 7.7 mg to about 77.0 mg per 70 kg patient, wherein the patient does not suffer from severe psychological impairments and side effects associated with Higher dose of THC post-administration of the composition. 
     
     
         4 . The composition of  claim 3 , wherein the dose amount of THC per 70 kg patient is from about 14 to about 1.4 mg. 
     
     
         5 . The composition of  claim 4 , wherein the dose amount of THC per 70 kg patient is from about 14 to about 1.0 mg. 
     
     
         6 . The composition of  claim 3 , wherein THC is selected from the group of organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A. 
     
     
         7 . The composition of  claim 3 , wherein the dose amount of melatonin per 70 kg patient is from about 7.7 mg to about 12 mg. 
     
     
         8 . The composition of  claim 7 , wherein the dose amount of melatonin per 70 kg patient is from about 7.7 mg to about 13 mg. 
     
     
         9 . The composition of  claim 8 , wherein the dose amount of melatonin per 70 kg patient is from about 7.7 mg to about 50 mg. 
     
     
         10 . A method for treating Alzheimer's disease, the method comprising administering THC and melatonin to a patient in need thereof, wherein THC is administered in an ultra-low dose amount per 70 kg patient of from about 14 μg to about 2.0 mg, wherein melatonin is administered in a dose amount per 70 kg patient of from about 7.7 mg to about 77.0 mg, and wherein the patient does not suffer from psychological impairments and side effects associated with higher doses of THC. 
     
     
         11 . A method for enhancing mitochondrial function in Alzheimer's patients comprising administering tetrahydrocannabinol (THC) and melatonin to a patient suffering from Alzheimer's disease, wherein the THC is administered in an ultra-low dose amount of from about 0.2 μg/kg to about 0.02 mg/kg of body weight of the patient and melatonin is administered in an amount from about 0.11 mg/kg to about 1.1 mg/kg of body weight of the patient. 
     
     
         12 . The method of  claim 11 , further comprising administering THC and melatonin at least one additional time at 6-hour intervals, 12-hour intervals, or 24-hour intervals. 
     
     
         13 . The method of  claim 11 , wherein the THC is selected from the group consisting of organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A. 
     
     
         14 . A method for decreasing the phosphorylation of GSK3β protein in Alzheimer's patients comprising administering tetrahydrocannabinol (THC) and melatonin to a patient suffering from Alzheimer's disease, wherein the THC is administered in an ultra-low dose amount of from about 0.2 μg/kg to about 0.02 mg/kg of body weight of the patient and melatonin is administered in an amount from about 0.11 mg/kg to about 1.1 mg/kg of body weight of the patient. 
     
     
         15 . The method of  claim 14 , further comprising administering THC and melatonin at least one additional time at 6-hour intervals, 12-hour intervals, or 24-hour intervals. 
     
     
         16 . The method of  claim 14 , wherein the THC is selected from the group consisting of organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A. 
     
     
         17 . A method for maintaining Tau protein expression in an Alzheimer's patient comprising administering tetrahydrocannabinol (THC) and melatonin to a patient suffering from Alzheimer's disease, wherein the THC is administered in an ultra-low dose amount of from about 0.2 μg/kg to about 0.02 mg/kg of body weight of the patient and melatonin is administered in an amount from about 0.11 mg/kg to about 1.1 mg/kg of body weight of the patient. 
     
     
         18 . The method of  claim 17 , further comprising administering THC and melatonin at least one additional time at 6-hour intervals, 12-hour intervals, or 24-hour intervals. 
     
     
         19 . The method of  claim 17 , wherein the THC is selected from the group consisting of organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A.