TREATMENT OF ALZHEIMER'S DISEASE SUBPOPULATIONS WITH POOLED IMMUNOGLOBULIN G
The present invention provides, among other aspects, methods for the treatment of Alzheimer's disease in a subject in need thereof, the method including administration of a therapeutically effective amount of a pooled human immunoglobulin G (IgG) composition to a subject with moderately severe Alzheimer's disease, a subject carrying an ApoE4 allele, or both, where the amount of pooled human IgG is from 300 mg/kg to 800 mg/kg body weight of the subject per two week period, and where the amount is administered in one or more doses during the two week period after initiation of a therapeutic regimen. Also provided, are methods for selecting a treatment regimen for a subject with Alzheimer's disease, including diagnosing the severity of the Alzheimer's disease, determining if the subject carries an APOE4 allele, or both, and assigning a treatment regimen including administration of pooled human immunoglobulin G and/or an anti-beta amyloid monoclonal antibody.
1 - 239 . (canceled)
240 . A method for treating Alzheimer's disIease, the method comprising administering from 300 mg/kg body weight to 800 mg/kg body weight pooled human immunoglobulin G (IgG) per two-week period to an Alzheimer's patient who does not display amyloid plaques.
241 . The method of claim 240 , comprising administering 400 mg/kg body weight pooled human IgG per two-week period to the Alzheimer's patient.
242 . The method of claim 240 , wherein the Alzheimer's patient has a Mini-Mental Status Examination (MMSE) score of from 16 to 22.
243 . The method of claim 240 , wherein the Alzheimer's patient has a Mini-Mental Status Examination (MMSE) score of from 16 to 20.
244 . The method of claim 240 , wherein the Alzheimer's patient carries an ApoE4 allele.
245 . The method of claim 242 , wherein the Alzheimer's patient carries an ApoE4 allele.
246 . A method for treating an Alzheimer's patient, comprising:
determining whether the patient displays beta-amyloid plaques, and
if the patient does not display amyloid plaques, then administering pooled human immunoglobulin G (IgG) to the patient, and
if the patient displays amyloid plaques, then forgoing administration of the pooled human IgG to the patient.
247 . The method of claim 246 , wherein the Alzheimer's patient has a Mini-Mental Status Examination (MMSE) score of from 16 to 22.
248 . The method of claim 246 , wherein the Alzheimer's patient has a Mini-Mental Status Examination (MMSE) score of from 16 to 20.
249 . The method of claim 246 , wherein the Alzheimer's patient carries an ApoE4 allele.
250 . The method of claim 247 , wherein the Alzheimer's patient carries an ApoE4 allele.
251 . The method of claim 246 , wherein the Alzheimer's patient is administered from 300 mg/kg body weight to 800 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
252 . The method of claim 247 , wherein the Alzheimer's patient is administered from 300 mg/kg body weight to 800 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
253 . The method of claim 249 , wherein the Alzheimer's patient is administered from 300 mg/kg body weight to 800 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
254 . The method of claim 250 , wherein the Alzheimer's patient is administered from 300 mg/kg body weight to 800 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
255 . The method of claim 246 , wherein the Alzheimer's patient is administered 400 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
256 . The method of claim 247 , wherein the Alzheimer's patient is administered 400 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
257 . The method of claim 249 , wherein the Alzheimer's patient is administered 400 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
258 . The method of claim 250 , wherein the Alzheimer's patient is administered 400 mg/kg body weight pooled human IgG if the patient does not display amyloid plaques.
259 . The method of claim 246 , wherein the Alzheimer's patient is administered a cholinesterase inhibitor or an NMDA-type glutamate receptor inhibitor if the patient displays amyloid plaques.