US2017319565A1PendingUtilityA1

Methods and drug products for treating alzheimer's disease

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Assignee: TAKEDA PHARMACEUTICALS COPriority: Jan 10, 2011Filed: May 22, 2017Published: Nov 9, 2017
Est. expiryJan 10, 2031(~4.5 yrs left)· nominal 20-yr term from priority
Inventors:Allen D. RosesRajneesh Taneja
A61P 25/28A61P 25/00Y10T436/143333C12Q 1/6883C12Q 2600/172C07D 417/12C12Q 2600/158A61K 31/4439C12Q 2600/118C12Q 2600/106C12Q 2600/156
56
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Claims

Abstract

Provided herein are drug products with low dose pioglitazone for use in the treatment (e.g., delay of onset) of cognitive impairment of the Alzheimer's type. Methods of manufacture thereof are also provided. Further provided are methods of treatment for Alzheimer's disease including administering a drug product with low dose pioglitazone. The methods may include determining whether the subject is at risk of developing Alzheimer's disease based upon the subject's age and TOMM40 523 genotype.

Claims

exact text as granted — not AI-modified
1 .- 81 . (canceled) 
     
     
         82 . A method of treating cognitive decline in a human subject in need thereof, comprising administering to said subject about 0.5 milligrams to about 9 milligrams of pioglitazone. 
     
     
         83 . The method of  claim 82 , wherein said treating comprises delaying the onset of cognitive decline. 
     
     
         84 . The method of  claim 82 , wherein said treating comprises delaying the onset of cognitive decline in a human subject at increased risk of developing cognitive decline within the next 5-7 years, said risk based upon the subject's age and rs10524523 genotype. 
     
     
         85 . The method of  claim 82 , wherein the low dose pioglitazone is administered in unit dosage form. 
     
     
         86 . The method of  claim 85 , wherein the unit dosage form comprises from 0.5 to 9 milligrams of pioglitazone. 
     
     
         87 . The method of  claim 85 , wherein the unit dosage form comprises from 0.5 to 6 milligrams of pioglitazone. 
     
     
         88 . The method of  claim 85 , wherein said unit dosage form comprises from 0.5 to 1.5 milligrams of pioglitazone. 
     
     
         89 . The method of  claim 82 , wherein said administering is once daily. 
     
     
         90 . The method of  claim 84 , wherein
 (i) the subject is about age 62 or more and has an L,L or L,VL genotype;   (ii) the subject is about age 74 or more and has an S,L genotype;   (iii) the subject is about age 76 or more and has an S,VL genotype; or   (iv) the subject is about age 77 or more and has an S,S genotype; and wherein the genotype is based on a length of poly-T residues at each allele at rs10524523 in the TOMM40 gene, and wherein   (a) S is the short poly-T length having less than 19 T residues;   (b) L is the long poly-T length having 19-29 T residues; and   (c) VL is the very long poly-T length having 30 or more T residues.   
     
     
         91 . The method of  claim 90 , wherein the subject is age 62 or more and has the L,L or L,VL genotype. 
     
     
         92 . The method of  claim 90 , wherein the subject is age 74 or more and has the S,L genotype. 
     
     
         93 . The method of  claim 90 , wherein the subject is age 76 or more and has the S,VL genotype. 
     
     
         94 . The method of  claim 90 , wherein the subject is age 77 or more and has the S,S genotype. 
     
     
         95 . The method of  90 , wherein said subject further does not have an ApoE genotype of ε2/ε2 or ε2/ε3. 
     
     
         96 . The method of  claim 90 , wherein 0.5 to 9 milligrams of pioglitazone is administered to said subject. 
     
     
         97 . The method of  claim 90 , wherein 0.5 to 6 milligrams of pioglitazone is administered to said subject. 
     
     
         98 . The method of  claim 90 , wherein 0.5 to 1.5 milligrams of pioglitazone is administered to said subject. 
     
     
         99 . The method of  claim 90 , wherein said subject has normal cognition. 
     
     
         100 . The method of  claim 90 , wherein 0.5 to 9 milligrams of pioglitazone is administered to said subject. 
     
     
         101 . The method of  claim 100 , wherein 0.5 to 6 milligrams of pioglitazone is administered to said subject. 
     
     
         102 . The method of  claim 100 , wherein 0.5 to 1.5 milligrams of pioglitazone is administered to said subject. 
     
     
         103 . The method of  claim 82 , wherein the pioglitazone is in an oral modified release formulation, controlled release formulation, or extended release formulation. 
     
     
         104 . The method of  claim 82 , wherein the subject has one or more symptoms of cognitive decline. 
     
     
         105 . The method of  claim 82 , wherein the pioglitazone comprises a pharmaceutically acceptable salt of pioglitazone. 
     
     
         106 . The method of  claim 82 , wherein the pioglitazone consists of a pharmaceutically acceptable salt of pioglitazone. 
     
     
         107 . The method of  claim 82 , wherein the pioglitazone comprises pioglitazone hydrochloride. 
     
     
         108 . The method of  claim 82 , wherein the pioglitazone consists of pioglitazone hydrochloride.

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