Dosing Regimens for Treating And/Or Preventing Cerebral Amyloidoses

Abstract

Described herein are dosing regimens and kits for the treatment and/or prevention of cerebral amyloidoses such as Alzheimer's disease (AD) and/or cerebral amyloid angiopathy (CAA).

What is claimed is: 
     
         1 . A method for preventing and/or treating Alzheimer's disease and/or cerebral amyloid angiopathy in a patient at risk for developing or diagnosed with the same, the method comprising:
 administering to the patient an effective amount of 2-acetamido-1,2-dideoxynojirimycin (AdDNJ) for a first enzyme enhancement period;   not administering the AdDNJ for a substrate turnover period; and then   administering to the patient an effective amount of AdDNJ for a second enzyme enhancement period.   
     
     
         2 . The method of  claim 1 , wherein the first enzyme enhancement period and the second enzyme enhancement period have the same duration. 
     
     
         3 . The method of  claim 1 , wherein one or more of the first enzyme enhancement period and the second enzyme enhancement period is a period of about 1 day to about 8 days. 
     
     
         4 . The method of  claim 2 , wherein one or more of the first enzyme enhancement period and the second enzyme enhancement period is a period of about 4 days to about 6 days. 
     
     
         5 . The method of  claim 1 , wherein the AdDNJ is administered daily during the first enzyme enhancement period and the second enzyme enhancement period. 
     
     
         6 . The method of  claim 1 , wherein the AdDNJ is administered orally. 
     
     
         7 . The method of  claim 1 , wherein the AdDNJ is administered at a dose in the range of about 3 mg/kg/day to about 300 mg/kg/day. 
     
     
         8 . The method of  claim 7 , wherein the AdDNJ is administered at a dose of about 100 mg/kg/day. 
     
     
         9 . The method of  claim 1 , wherein not administering the AdDNJ for the substrate turnover period comprises not administering AdDNJ for a period of about 48 hours to about 96 hours. 
     
     
         10 . The method of  claim 9 , wherein not administering the AdDNJ for the substrate turnover period comprises not administering AdDNJ for a period of about 72 hours. 
     
     
         11 . The method of  claim 1 , wherein the first enzyme enhancement period is about 5 days and not administering the AdDNJ for the substrate turnover period comprises not administering AdDNJ for a period of about 72 hours. 
     
     
         12 . The method of  claim 1 , wherein the method comprises:
 administering to the patient an effective amount of AdDNJ on a first day;   not administering the AdDNJ on a second day;   administering to the patient an effective amount of AdDNJ on a third day;   not administering the AdDNJ on a fourth day;   administering to the patient an effective amount of AdDNJ on a fifth day; and then   not administering the AdDNJ for a period of about 72 hours   
     
     
         13 . The method of  claim 1 , wherein not administering the AdDNJ for a substrate turnover period comprises not administering AdDNJ for a period of about 24 hours. 
     
     
         14 . The method of  claim 1 , wherein not administering the AdDNJ for a substrate turnover period comprises not administering AdDNJ for a period of about 48 hours. 
     
     
         15 . The method of  claim 1 , wherein the first enzyme enhancement period is about 3 days and not administering the AdDNJ for the substrate turnover period comprises not administering AdDNJ for a period of about 120 hours. 
     
     
         16 . The method of  claim 1 , wherein the method comprises alternating between enzyme enhancement periods and substrate turnover periods for a total treatment time of at least 1 month. 
     
     
         17 . The method of  claim 16 , wherein the total treatment time is at least 3 months. 
     
     
         18 . The method of  claim 16 , wherein at least one substrate turnover period has a different duration than at least one other substrate turnover period. 
     
     
         19 . A kit comprising:
 one or more dosage forms comprising an effective amount of 2-acetamido-1,2-dideoxynojirimycin (AdDNJ); and   instructions for:
 administering the dosage forms for a first enzyme enhancement period; 
 not administering the dosage forms for a substrate turnover period; and then 
 administering the dosage forms for a second enzyme enhancement period. 
   
     
     
         20 . A kit comprising:
 one or more active dosage forms comprising an effective amount of 2-acetamido-1,2-dideoxynojirimycin (AdDNJ);   one or more inactive dosage forms that do not comprise an effective amount of AdDNJ; and   instructions for:
 administering the active dosage forms for a first enzyme enhancement period; 
 administering the inactive dosage forms for a substrate turnover period; and then 
 administering the active dosage forms for a second enzyme enhancement period.