received by the International Bureau on 13 April 2018 (13.04.2018)

1. A method for the treatment and/or prevention of Alzheimer's disease comprising administering a pharmaceutically effective amount of a formulation comprising S-equol to a subject in need thereof, wherein the formulation is essentially free of genistein, daidzein, IBS003569 and R-equol.

2. The method of Claim 1, wherein the subject has been diagnosed with Alzheimer's disease.

3. The method of Claim 1, wherein the subject is at risk of developing Alzheimer's disease.

4. The method of Claim 1, wherein said subject is a human.

5. The method of Claim 4, wherein said subject is a human above the age of 50.

6. The method of Claim 1, wherein the S-equol is produced chemically.

7. The method of Claim 1, wherein the S-equol is not produced biosynthetically or by

biotransformation.

8. The method of Claim 1, wherein the S-equol is a single anhydrous crystalline polymorph having the following characteristic X-ray powder diffraction partem wavenumbers (cm^-1): 3433, 3023, 3003, 2908, 2844, 1889, 1614, 1594, 1517, 1508, 1469, 1454, 1438, 1400, 1361, 1323,1295, 1276, 1261, 1234, 1213, 1176, 1156, 1116, 1064, 1020, 935, 897, 865, 840,8 25, 810, 769, 734, 631, 616, 547, 517, 480, and 461.

9. The method of Claim 1, wherein genistein, daidzein, and/or IBS003569 are not co-administered with S-equol.

10. A method of diagnosing or determining the risk of developing Alzheimer's disease in a subject, comprising

obtaining a blood sample from a subject;

directly measuring the activity of one or more mitochondria target biomarker(s) in said blood sample; and

comparing the activity of the one or more mitochondria target biomarker(s) to a library having activity data of the one or more mitochondrial target engagement biomarker(s) from one or more subjects diagnosed with Alzheimer's disease.

11. The method of Claim 10, wherein the sequence of steps is repeated at least one or more times to determine the relative changes in activity of the one or more mitochondria target biomarker(s) in said subject.

12 The method of Claim 10, wherein the mitochondria target biomarker is a respiratory chain enzyme.

13. The method of Claim 10, wherein the mitochondria target biomarker is platelet mitochondria cytochrome oxidase (COX) activity.

14. The method of Claim 10, wherein the mitochondria target biomarker is citrate synthase (CS) activity.

15. The method of Claim 10, further comprising the step of administering a formulation comprising a pharmaceutically effective amount of S-equol to said subject.

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16. The method of Claim 15, wherein the formulation is essentially free of genistein, daidzein, and/or IBS003569.

17. The method of Claim 15, wherein genistein. daidzein, and/or IBS003569 are not co-administered with S-equol.

18. The method of Claim 10, further comprising determining the genotype of said subject.

19. The method of Claim 10, wherein said subject is a human.

20. The method of Claim 19, wherein said subject is a human above the age of 50.

21. The method of Claim 15, wherein S-equol is produced chemically.

22. The method of Claim 15, wherein the S-equol is not produced biosynthetically or by

biotransformation.

23. The method of Claim 15, wherein the formulation is essentially free of genistein, daidzein, and/or IBS003569.

24. The method of Claim 15, wherein the formulation is essentially free of R-equol.

25. The method of Claim 15, wherein the S-equol is a single anhydrous crystalline polymorph having the following characteristic X-ray powder diffraction partem wavenumbers (cm^"1): 3433, 3023, 3003, 2908, 2844, 1889, 1614, 1594, 1517, 1508, 1469, 1454, 1438, 1400, 1361, 1323, 1295, 1276, 1261, 1234, 1213. 1176, 1156, 1 1 16, 1064, 1020, 935, 897, 865, 840,8 25, 810, 769, 734, 631, 616, 547, 517, 480, and 461.

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26. The method of Claim 15, wherein the S-equol is administered in the absence of any amount of genistein, daidzein, and/or IBS003569.

27. The method of Claim 15, wherein genistein, daidzein, and/or IBS003569 are not co-administered with S-equol.

28. The method of Claim 10, further comprising determining whether said subject is an

apolipoprotein E4 (APOE4) carrier.

29. The method of Claim 28, further comprising, if said subject is not an apolipoprotein E4 (APOE4) carrier, the step of administering a pharmaceutically effective amount of S-equol to said subject.

30. A method for alleviating or preventing cognitive decline associated with menopause in a subject, comprising administering to the subject an effective amount of a formulation comprising an amount of S-equol sufficient to alleviate or prevent said cognitive decline, wherein said formulation is essentially free of genistein, daidzein, IBS003569 and R-equol.

31. The method of Claim 30, wherein the subject is human.

32. The method of Claim 31, wherein said subject is a human above the age of 50.

33. The method of Claim 30, wherein the S-equol is produced chemically.

34. The method of Claim 30, wherein the S-equol is a single anhydrous crystalline polymorph having the following characteristic X-ray powder diffraction pattem wavenumbers (cm^-1): 3433, 3023, 3003, 2908, 2844, 1889, 1614, 1594, 1517, 1508, 1469, 1454, 1438, 1400, 1361, 1323,1295, 1276, 1261, 1234, 1213, 1176, 1156, 1116, 1064, 1020, 935, 897, 865, 840,8 25, 810, 769, 734, 631, 616, 547,

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35. The method of Claim 30, wherein the S-equol is not produced biosynthetically or by

biotransformation.

36. The method of Claim 30, wherein genistein, daidzein, and/or IBS003569 are not co-administered with S-equol.

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