US2002192725A1PendingUtilityA1

Relation of apolipoprotein E genotype and estrogen deprivation in alzheimer's disease

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Priority: Oct 22, 1999Filed: Jun 26, 2002Published: Dec 19, 2002
Est. expiryOct 22, 2019(expired)· nominal 20-yr term from priority
Inventors:Gillian EinsteinLaura W. ShaughnessyDonald E. Schmechel
C12Q 1/6883C12Q 2600/106C12Q 2600/156C12Q 2600/172
44
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Claims

Abstract

A method of screening a subject for risk of developing Alzheimer's disease comprises determining the presence of at least one ApoE4 allele in a subject, and determining the presence or absence of decreased estrogen levels in said subject (e.g., due to previous or impending menopause or hysterectomy). The presence of at least one ApoE4 allele (and particularly two ApoE4 alleles) in combination with decreased estrogen levels in said subject indicating said subject is at greater risk of developing Alzheimer's disease (e.g., as compared to subjects with at corresponding number of ApoE4 alleles, but who do not have decreased estrogen levels), and that the subject will receive greater benefit from estrogen replacement therapy in treating Alzheimer's disease than a subject who does not carry one or two ApoE4 alleles.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A method of screening a human female subject for risk of developing Alzheimer's disease, comprising: 
 (a) determining the presence of at least one ApoE4 allele in a subject, and    (b) determining the presence or absence of decreased estrogen levels in said subject;    the presence of at least one ApoE4 allele in combination with decreased estrogen levels in said subject indicating said subject is at greater risk of developing Alzheimer's disease.    
     
     
         2 . A method according to  claim 1 , wherein said step of determining the presence of at least one ApoE4 allele is carried out by collecting a biological sample containing DNA from said subject, and then detecting the presence or absence of DNA encoding ApoE4 in said biological sample.  
     
     
         3 . A method according to  claim 2 , wherein said detecting step is carried out by amplifying DNA encoding ApoE4.  
     
     
         4 . A method according to  claim 1 , wherein said step of determining the presence of at least one ApoE4 allele is carried out by collecting an ApoE sample from said subject, and then detecting the presence or absence of the ApoE4 isoform in said ApoE sample.  
     
     
         5 . A method according to  claim 1 , wherein said subject has previously been determined to have one or more factors indicating that such subject is afflicted with Alzheimer's disease.  
     
     
         6 . A method according to  claim 1 , wherein said determining step comprises detecting whether said subject is homozygous for the gene encoding ApoE4.  
     
     
         7 . A method for screening a human female subject for responsiveness to estrogen replacement therapy for the treatment of Alzheimer's disease, comprising: 
 determining the presence of at least on ApoE4 allele in said subject, wherein the presence of at least one apoE4 gene allele indicates said subject will receive greater benefit from estrogen replacement therapy that a subject who does not carry at least one ApoE4 allele.    
     
     
         8 . A method according to  claim 7 , wherein said step of determining the presence of at least one ApoE4 allele is carried out by collecting a biological sample containing DNA from said subject, and then detecting the presence or absence of DNA encoding ApoE4 in said biological sample.  
     
     
         9 . A method according to  claim 8 , wherein said detecting step is carried out by amplifying DNA encoding ApoE4.  
     
     
         10 . A method according to  claim 7 , wherein said step of determining the presence of at least one ApoE4 allele is carried out by collecting an ApoE sample from said subject, and then detecting the presence or absence of the ApoE4 isoform in said ApoE sample.  
     
     
         11 . A method according to  claim 7 , wherein said subject has previously been determined to have one or more factors indicating that such subject is afflicted with Alzheimer's disease.  
     
     
         12 . A method according to  claim 7 , wherein said determining step comprises detecting whether said subject is homozygous for the gene encoding ApoE4.  
     
     
         13 . A method for treating a human female subject for Alzheimer's disease, comprising: 
 (a) determining the presence of at least on ApoE4 allele in said subject; and then    (b) administering estrogen replacement therapy to said subject in an Alzheimer's disease treatment effective amount.    
     
     
         14 . A method according to  claim 13 , wherein said administering step is carried out by orally administering an estrogenic agent to said subject.  
     
     
         15 . A method according to  claim 13 , wherein said administering step is carried out by transdermally administering an estrogenic agent to said subject.  
     
     
         16 . A method according to  claim 13 , wherein said estrogen replacement therapy includes the step of administering a progestationally active compound to said subject in an amount effective to inhibit estrogenic endometrial proliferation.  
     
     
         17 . A method according to  claim 13 , wherein said step of determining the presence of at least one ApoE4 allele is carried out by collecting a biological sample containing DNA from said subject, and then detecting the presence or absence of DNA encoding ApoE4 in said biological sample.  
     
     
         18 . A method according to  claim 17 , wherein said detecting step is carried out by amplifying DNA encoding ApoE4.  
     
     
         19 . A method according to  claim 13 , wherein said step of determining the presence of at least one ApoE4 allele is carried out by collecting an ApoE sample from said subject, and then detecting the presence or absence of the ApoE4 isoform in said ApoE sample.  
     
     
         20 . A method according to  claim 13 , wherein said subject has previously been determined to have one or more factors indicating that such subject is afflicted with Alzheimer's disease.  
     
     
         21 . A method according to  claim 13 , wherein said determining step comprises detecting whether said subject is homozygous for the gene encoding ApoE4.  
     
     
         22 . A method of treating a human female subject for Alzheimer's disease, said method comprising the steps of: 
 selecting a subject that carries at least on ApoE4 allele, and then    administering estrogen replacement therapy to said subject in an Alzheimer's disease treatment effective amount.    
     
     
         23 . A method according to  claim 22 , wherein said administering step is carried out by orally administering an estrogenic agent to said subject.  
     
     
         24 . A method according to  claim 22 , wherein said administering step is carried out by transdermally administering an estrogenic agent to said subject.  
     
     
         25 . A method according to  claim 22 , wherein said estrogen replacement therapy includes the step of administering a progestationally active compound to said subject in an amount effective to inhibit estrogenic endometrial proliferation.

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