Methods of maintaining, treating or improving cognitive function
View Patent ↗A method of administering an effective amount of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof, to a patient in need thereof.
1. A method of treating a patient having a cognitive impairment, comprising:
administering to the patient, for an extended period of at least 12 weeks, a daily dose of a pharmaceutical composition comprising (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof;
wherein the cognitive impairment is limited cognitive impairment (LCI), mild cognitive impairment (MCI), Alzheimer's disease, or dementia of the Alzheimer's-type;
wherein the patient has scored a sub-normal value on one or more cognitive assessment tests, comprising: MMSE, ADAS-Cog-13, ADAS-Cog-11, COWAT, CFT, or CDR-SB.
2. The method of claim 1 , wherein the Alzheimer's disease is mild-to-moderate Alzheimer's disease.
3. The method of claim 1 , wherein the patient has scored a sub-normal value on one or more cognitive assessment tests, comprising: ADAS-Cog-13, ADAS-Cog-11, COWAT, CFT, or CDR-SB.
4. The method of claim 1 , wherein the patient has scored a sub-normal value on an MMSE test.
5. The method of claim 1 , wherein the patient has scored >14 to <24 on a MMSE test or a score of >2 on a CDR-SB test.
6. The method of claim 1 , wherein the daily dose is between 1.0 mg and 4.5 mg of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof.
7. The method of claim 1 , wherein the daily dose is 0.3 mg, 1.0 mg, 2.0 mg, or 3.0 mg, of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof.
8. The method of claim 1 , wherein the extended period is at least 23 weeks.
9. The method of claim 1 , wherein the extended period is at least 24 weeks.
10. The method of claim 1 , wherein the method improves one or more cognitive or behavioral symptoms associated with the cognitive impairment.
11. The method of claim 1 , wherein the method improves cognition in said cognitively impaired patient.
12. The method of claim 1 , wherein the method provides a positive effect on cognition or a positive effect on clinical function in said cognitively impaired patient.
13. The method of claim 1 , wherein the method provides a pro-cognitive effect in at least one of the following: visual motor, learning, delayed memory, or executive function, in said patient.
14. The method of claim 1 , wherein said patient has been previously treated or is currently being treated with an AChEI.
15. The method of claim 1 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate.
16. The method of claim 1 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate, polymorph form I.
17. The method of claim 1 , wherein the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof, is administered in the form of a pharmaceutical composition comprising at least one pharmaceutically acceptable carrier, excipient or diluent.
18. The method of claim 1 , wherein the pharmaceutical composition is in the form of a tablet.
19. The method of claim 1 , wherein the cognitive impairment is limited cognitive impairment (LCI).
20. The method of claim 1 , wherein the cognitive impairment is mild cognitive impairment (MCI).
21. The method of claim 1 , wherein the cognitive impairment is Alzheimer's disease.
22. The method of claim 1 , wherein the cognitive impairment is dementia of the Alzheimer's-type.
23. A method of treating a patient having Alzheimer's disease, comprising:
administering to the patient, for an extended period of at least 23 weeks, a daily dose of between 1.0 mg and 4.5 mg of a pharmaceutical composition comprising (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof;
wherein the patient has scored a sub-normal value on one or more cognitive assessment tests, comprising: MMSE, ADAS-Coq-13, ADAS-Coq-11, COWAT, CFT, or CDR-SB.
24. The method of claim 23 , wherein the daily dose is 1.0 mg of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or pharmaceutically acceptable salt thereof.
25. The method of claim 23 , wherein the daily dose is 2.0 mg of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or pharmaceutically acceptable salt thereof.
26. The method of claim 23 , wherein the daily dose is 3.0 mg of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or pharmaceutically acceptable salt thereof.
27. The method of claim 23 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate.
28. The method of claim 23 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate, polymorph form I.
29. The method of claim 23 , wherein the method improves one or more cognitive or behavioral symptoms associated with the Alzheimer's disease.
30. The method of claim 23 , wherein the method improves cognition in said Alzheimer's disease patient.
31. The method of claim 23 , wherein the method provides a positive effect on cognition or a positive effect on clinical function in said Alzheimer's disease patient.
32. A method of treating a patient having mild-to-moderate Alzheimer's disease, comprising:
administering to the patient, for an extended period of at least 23 weeks, a daily dose of between 1.0 mg and 4.5 mg of a pharmaceutical composition comprising (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof;
wherein the patient has scored a sub-normal value on one or more cognitive assessment tests, comprising: MMSE, ADAS-Cog-13, ADAS-Cog-11, COWAT, CFT, or CDR-SB.
33. The method of claim 32 , wherein the daily dose is 1.0 mg of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or pharmaceutically acceptable salt thereof.
34. The method of claim 32 , wherein the daily dose is 2.0 mg of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or pharmaceutically acceptable salt thereof.
35. The method of claim 32 , wherein the daily dose is 3.0 mg of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or pharmaceutically acceptable salt thereof.
36. The method of claim 32 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate.
37. The method of claim 32 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate, polymorph form I.
38. The method of claim 32 , wherein the method improves one or more cognitive or behavioral symptoms associated with the mild-to-moderate Alzheimer's disease.
39. The method of claim 32 , wherein the method improves cognition in said mild-to-moderate Alzheimer's disease patient.
40. The method of claim 32 , wherein the method provides a positive effect on cognition or a positive effect on clinical function in said mild-to-moderate Alzheimer's disease patient.