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1. (WO2018039030) METHODS FOR DETECTING AND/OR PREDICTING AGE-RELATED MACULAR DEGENERATION AND/OR ALZHEIMER'S DISEASE
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CLAIMS

That which is claimed is:

1. A method of detecting and/or diagnosing age-related macular degeneration or Alzheimer's disease in retina tissue of a subject, the method comprising:

administering a hydroxyapatite-selective fluorescent dye to the retina tissue in an amount sufficient for binding to any hydroxyapatite (HAP) deposits or spherules in the retina tissue to form a HAP/ hydroxyapatite-selective fluorescent dye complex;

irradiating the HAP/hydroxyapatite-selective fluorescent dye complex with electromagnetic radiation in an amount sufficient to excite the HAP/hydroxyapatite-selective fluorescent dye complex; and

monitoring and/or measuring the lifetime of a fluorescent signal of the HAP/hydroxyapatite-selective fluorescent dye complex with a fluorescence lifetime imaging device, wherein the HAP/hydroxyapatite-selective fluorescent dye complex exhibits a longer fluorescence lifetime signal than that of background fluorescence of retina tissue.

2. The method according to claim 1, wherein the fluorescence lifetime imaging device is selected from a device using time or frequency domain technologies, time-gated photon counting with laser scanning, time-correlated single photon counting, streak camera, or wide-field imaging techniques.

3. The method according to claim 1 , wherein the hydroxyapatite-selective fluorescent dye is selected from the group consisting of chlortetracycline, demeclocycline, doxycycline, methacycline, oxycycline, anhydrochlortetracycline, anhydrotetracycline, and chelocardin.

4. The method according to claim 1, wherein the tetracycline derivative is administered topically, orally, or by injection.

5. A method of detecting age-related macular degeneration and/or Alzheimer's disease in retina tissue of a subject, the method comprising:

administering a tetracycline derivative to the retina tissue in an amount sufficient for binding to any HAP deposits or spherules in the retina tissue to form a HAP/tetracycline derivative complex;

irradiating the HAP/tetracycline derivative complex with electromagnetic radiation in an amount and within a wavelength range sufficient to excite the tetracycline derivative; and monitoring and/or measuring the lifetime of a fluorescent signal of the HAP/tetracycline derivative complex with a fluorescence lifetime imaging device.

6. The method according to claim 5, wherein the fluorescence lifetime imaging device is selected from a device using time or frequency domain technologies, time-gated photon counting with laser scanning, time-correlated single photon counting, streak camera, or wide-field imaging techniques.

7. The method according to claim 5, wherein the tetracycline derivative is selected from the group consisting of chlortetracycline, demeclocycline, doxycycline, methacycline, oxycycline, anhydrochlortetracycline, anhydrotetracycline, and chelocardin.

8. The method according to claim 5, wherein the tetracycline derivative is administered topically, orally, or by injection.

9. A method for predicting or diagnosing age-related macular degeneration and/or Alzheimer's disease in a subject by detecting HAP deposits in the retina tissue of the subject, the method comprising:

administering a tetracycline derivative to the subject in an amount sufficient for binding to any HAP deposits in the retina tissue of the subject;

irradiating the retina tissue with electromagnetic radiation in an amount sufficient to excite the tetracycline derivative;

scanning the retina tissue of the subject with a fluorescence lifetime imaging device and monitoring the lifetime of a fluorescent signal of any bound tetracycline derivative to HAP deposits;

obtaining a profile of HAP deposits in the subject, wherein the HAP deposits bound to the tetracycline derivative exhibit a longer lifetime fluorescence signal compared to the lifetime fluorescence signal of the background tissue; and

using the obtained profile to diagnose or predict age-related macular degeneration and/or Alzheimer's disease in the subject.

10. The method according to claim 9, wherein the tetracycline derivative bound to the HAP deposits has a fluorescence lifetime from about 1.2 to about 6 nsec.

11. The method according to claim 9, wherein the background tissue has a fluorescence lifetime from about 0.2 to about 0.7 nsec.

12. The method according to claim 9, wherein the tetracycline derivative is selected from the group consisting of chlortetracycline, demeclocycline, doxycycline, methacycline, oxycycline, anhydrochlortetracycline, anhydrotetracycline, and chelocardin.

13. The method according to claim 9, wherein the profile is compared with a set of controls, wherein the set of controls comprise different levels of HAP deposits representing a particular stage of age-related macular degeneration and a control with no HAP deposits.

14. The method according to claim 9, wherein the tetracycline derivative is administered topically, orally or by injection.

15. A method for identifying or labeling of drusen or HAP deposits in retina tissue to be used in diagnosing or predicting the likelihood of having or developing age-related macular degeneration, the method comprising:

administering a tetracycline derivative to the retina tissue in an amount sufficient for binding to any drusen or HAP deposits in the retina tissue;

irradiating the tetracycline derivative with electromagnetic radiation in an amount sufficient to excite the tetracycline derivative;

scanning the retina tissue with a fluorescence lifetime imaging device;

measuring and monitoring the lifetime of a fluorescent signal of any bound tetracycline derivative to drusen or HAP deposits; and

obtaining a profile of drusen or HAP deposits in the retina tissue, and using the obtained profile to diagnose or predict age-related macular degeneration.

16. The method according to claim 15, wherein the tetracycline derivative is administered topically, orally, or by injection.

17. A method for identifying HAP deposits in peripheral retina tissue to be used in diagnosing or predicting the likelihood of having or developing Alzheimer's disease, the method comprising:

administering a tetracycline derivative to the peripheral retina tissue in an amount sufficient for binding to any HAP deposits in the peripheral retina tissue;

irradiating the tetracycline derivative with electromagnetic radiation in an amount sufficient to excite the tetracycline derivative;

scanning the peripheral retina tissue with a fluorescence lifetime imaging device; measuring the lifetime of a fluorescent signal of any bound tetracycline derivative to HAP deposits, wherein the fluorescent signal of any bound tetracycline derivative to HAP deposits exhibits a longer fluorescence lifetime signal than that of background fluorescence of the background tissue; and

obtaining a profile of HAP deposits in the peripheral retina tissue, and using the obtained profile to diagnose or predict the likelihood of having or developing Alzheimer's disease.

18. The method according to claim 17, wherein the fluorescence lifetime imaging device is selected from a device using time or frequency domain technologies, time-gated photon counting with laser scanning, point scanning or wide-field imaging techniques.

19. The method according to claim 17, wherein the HAP deposits bound to the tetracycline derivative has a fluorescence lifetime from about 1.2 to about 6 nsec.

20. The method according to claim 17, wherein the background tissue has a fluorescence lifetime from about 0.2 to about 0.7 nsec.

21. The method according to claim 17, wherein the tetracycline derivative is selected from the group consisting of chlortetracycline, demeclocycline, doxycycline, methacycline, oxycycline, anhydrochlortetracycline, anhydrotetracycline, and chelocardin.

22. The method according to claim 17, wherein the tetracycline derivative is administered topically, orally, or by injection.

23. The method according to claim 17, wherein the profile is compared with a set of controls, wherein the set of controls comprise different levels of HAP deposits representing a particular stage of age-related macular degeneration and a control with no HAP deposits.