Treatment of alzheimer's disease (ad) with an aluminum salt

Abstract

Disclosed is a method for the treatment of AD, wherein an immune stimulating pharmaceutical composition comprising an aluminium salt is administered to a patient having AD or having a risk to develop AD in an effective amount.

1 - 21 . (canceled) 
     
     
         22 . A method for treating Alzheimer's Disease (AD) comprising administering to a patient having AD a pharmaceutical formulation comprising from about 1.2 mg to about 5.0 mg of an aluminum salt. 
     
     
         23 . The method according to  claim 22 , wherein the method comprises the step of administering to the patient a diagnostic test that is capable of detecting early stage AD. 
     
     
         24 . The method according to  claim 23 , wherein the diagnostic test comprises a mini-mental state examination (MMSE). 
     
     
         25 . The method according to  claim 22 , wherein the diagnostic test comprises PET imaging, MRI imaging or measuring a cerebrospinal fluid marker. 
     
     
         26 . The method of  claim 25 , wherein the cerebrospinal fluid marker is selected from tau, amyloidβ42 or phospho-tau. 
     
     
         27 . The method according to  claim 22 , wherein the aluminum salt has the general formula Me a   + Al b   3+ An c   − .nH 2 O, wherein
 Me +  is Na + , K + , Li + , Rb + , Cs +  or NH 4   + ;   An is PO 4   3− , SO 4   2− O(OH) 3− , O 2−  or OH − ;   a is 0, 1, 2, or 3;   b is 1 or 2;   c is 1, 2, 3, 4, 5, or 6; and   n is 0 to 48.   
     
     
         28 . The method according to  claim 22 , wherein the aluminum salt comprises aluminum hydroxide, aluminum oxyhydroxide, aluminum phosphate, or aluminum sulfate. 
     
     
         29 . The method according to  claim 22 , wherein the pharmaceutical formulation is administered to the patient at least once monthly in a single administration dose. 
     
     
         30 . The method according to  claim 29 , wherein the pharmaceutical formulation comprises from about 1.5 mg to about 3.0 mg of the aluminum salt. 
     
     
         31 . The method according to  claim 30 , wherein the pharmaceutical formulation comprises about 2.0 mg of the aluminum salt. 
     
     
         32 . The method according to  claim 22 , wherein the pharmaceutical formulation comprises a pharmaceutically acceptable carrier, diluent or excipient. 
     
     
         33 . The method according to  claim 32 , wherein the pharmaceutical formulation comprises an aluminum oxyhydroxide suspension. 
     
     
         34 . The method according to  claim 33 , wherein the aluminum oxyhydroxide suspension has a particle size distribution between about 2 μm and about 10 μm. 
     
     
         35 . The method according to  claim 34 , wherein the pharmaceutical formulation is substantially devoid of sulfate, nitrate, or chloride anions 
     
     
         36 . The method according to  claim 35 , wherein the pharmaceutical formulation has a heavy metal content of less than about 20 ppm. 
     
     
         37 . The method according to  claim 36 , wherein the suspension is isotonic. 
     
     
         38 . The method according to  claim 22 , wherein the aluminum salt is aluminum oxyhydroxide and is administered to the patient subcutaneously, intranodally, intradermally, or intramuscularly. 
     
     
         39 . The method according to  claim 38 , comprising administering the aluminum salt to the patient subcutaneously in the upper arm. 
     
     
         40 . The method according to  claim 22 , wherein the aluminum salt is aluminum oxyhydroxide and is administered to the patient at least once monthly for at least two years. 
     
     
         41 . The method according to  claim 22 , wherein the aluminum salt is aluminum oxyhydroxide and is administered to the patient by an injection device. 
     
     
         42 . The method according to  claim 22 , wherein the aluminum salt is aluminum oxyhydroxide and is administered to the patient in liquid form in a volume of from about 0.1 to about 10 ml.