Methods for treating Alzheimer's disease

1. A method of treating Alzheimer's disease in a human patient suffering from Alzheimer's disease comprising administering an effective amount of a hydroxypropyl beta-cyclodextrin composition.

2. The method according to claim 1 , wherein the patient has progression of the Alzheimer's disease after previous administration of another therapy.

3. The method according to claim 2 , wherein the previous administration of another therapy is a therapy for Alzheimer's disease.

4. The method according to claim 1 , wherein the human patient is at least 50 years old.

5. The method according to claim 1 , wherein the human patient is at least 60 years old.

6. The method according to claim 1 , wherein the human patient is at least 65 years old.

7. The method according to claim 1 , wherein the human patient is at least 70 years old.

8. The method according to claim 1 , wherein the human patient is at least 80 years old.

9. The method according to claim 1 , further comprising administering the hydroxypropyl-beta-cyclodextrin composition in a monthly dose amount of about 500 mg/kg to about 1500 mg/kg.

10. The method according to claim 9 , wherein the monthly dose amount is from about 500 mg/kg to about 1000 mg/kg.

11. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered by parenteral administration.

12. The method according to claim 1 , further comprising administering the hydroxypropyl-beta-cyclodextrin composition in a monthly dose amount of about 100 mg to about 750 mg.

13. The method according to claim 12 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered by central nervous system (CNS) directed administration.

14. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered once a month.

15. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered twice a month.

16. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered weekly.

17. The method according to claim 10 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered intravenously.

18. The method according to claim 10 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered subcutaneously.

19. The method according to claim 10 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered by intrathecal administration.

20. The method according to claim 10 , wherein the hydroxypropyl-beta-cyclodextrin composition is administered by intracerebroventricular administration.

21. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition comprises a 25% (w/v) solution of one or more hydroxypropyl-beta-cyclodextrin species.

22. The method according to claim 1 , further comprising administering the hydroxypropyl-beta-cyclodextrin composition in a monthly escalating dose regimen until a maximum tolerated dose is determined, and subsequently administering the maximum tolerated dose.

23. The method according to claim 1 , further comprising administering the hydroxypropyl-beta-cyclodextrin composition monthly for at least 12 months.

24. The method according to claim 1 , further comprising administering a second therapeutic agent selected from the group consisting of donepezil, rivastigmine, galantamine, memantine, verubecestat, solanezumab, bapineuzumab, aducanumab, tideglusib, epothilone D and ABBV-8E12.

25. The method according to claim 1 , further comprising administering a second therapeutic agent selected from the group consisting of a cholinesterase inhibitor, an NMDA receptor antagonist, a humanized antibody which targets tau protein, a humanized antibody which targets amyloid beta protein, and a BACE inhibitor.

26. The method according to claim 1 , further comprising administering a second therapeutic agent, wherein the second therapeutic agent is selected from any therapeutic agent set forth in Table 1.

27. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition comprises a mixture of two or more hydroxypropyl-beta-cyclodextrin species, wherein each of the two or more hydroxypropyl-beta-cyclodextrin species has a different degree of hydroxypropylation of the beta-cyclodextrin ring, and wherein the mixture of two or more hydroxypropyl-beta-cyclodextrin species has a molar substitution value from about 0.59 to about 0.73.

28. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition comprises 2.5% w/w or less of propylene glycol.

29. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition comprises a mixture of two or more hydroxypropyl-beta-cyclodextrin species, wherein each of the two or more hydroxypropyl-beta-cyclodextrin species has a different degree of hydroxypropylation of the beta-cyclodextrin ring, and wherein the hydroxypropyl-beta-cyclodextrin composition comprises 0.15% w/w or less of unsubstituted beta-cyclodextrin.

30. The method according to claim 1 , wherein the hydroxypropyl-beta-cyclodextrin composition comprises a mixture of two or more hydroxypropyl-beta-cyclodextrin species, wherein each of the two or more hydroxypropyl-beta-cyclodextrin species has a different degree of hydroxypropylation of the beta-cyclodextrin ring, wherein the mixture of two or more hydroxypropyl-beta-cyclodextrin species has a molar substitution value from about 0.59 to about 0.73, and wherein the hydroxypropyl-beta-cyclodextrin composition comprises 2.5% w/w or less of propylene glycol and 0.15% w/w or less of unsubstituted beta-cyclodextrin.

31. A method of treating Alzheimer's disease in a human patient suffering from Alzheimer's disease, the method comprising administering to the human patient an effective amount of a hydroxypropyl beta-cyclodextrin composition, wherein the hydroxypropyl-beta-cyclodextrin composition comprises a mixture of two or more hydroxypropyl-beta-cyclodextrin species, and wherein the mixture of two or more hydroxypropyl-beta-cyclodextrin species has a molar substitution value from about 0.59 to about 0.73.

32. A method of treating Alzheimer's disease in a human patient suffering from Alzheimer's disease, the method comprising:

(a) administering to the human patient an initial 500 mg/kg dose by parenteral administration or an initial dose of 100 mg by CNS directed administration, of a hydroxypropyl-beta-cyclodextrin composition; and

(b) administering to the human patient the hydroxypropyl-beta-cyclodextrin composition in a monthly escalating dose regimen until a maximum tolerated dose is determined.

33. The method of claim 32 , further comprising administering the maximum tolerated dose of the hydroxypropyl beta-cyclodextrin composition once a month for 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, or 12 months.

34. The method of claim 32 , further comprising administering the maximum tolerated dose of the hydroxypropyl-beta-cyclodextrin composition once a month for up to the duration of the life span of the human patient.

35. A method of treating Alzheimer's disease in a human patient suffering from Alzheimer's disease comprising administering a hydroxypropyl beta-cyclodextrin composition to the patient wherein the monthly dose amount is 500 mg/kg.

36. The method according to claim 35 wherein the hydroxypropyl-beta-cyclodextrin composition is administered by parenteral administration.

37. A method of treating Alzheimer's disease in a human patient suffering from Alzheimer's disease comprising administering a hydroxypropyl beta-cyclodextrin composition to the patient wherein the monthly dose amount is 1000 mg/kg.

38. The method according to claim 37 wherein the hydroxypropyl-beta-cyclodextrin composition is administered by parenteral administration.