Patent ID: 8263589

Claim:
A method of treatment of a synucleinopathy, which synucleinopathy results in a neurodegenerative disease state and/or clinical dementia, which method comprises orally administering to a subject a therapeutically effective amount of a diaminophenothiazine compound having the following formula: wherein each one of R 1 , R 2 , R 4 , R 6 , R 8 , and R 9 is independently selected from: —H; —F; —Cl; —Br; —I; —OH; —OR; —SH; —SR; —NO 2 ; —C(═O)R; —C(═O)OH; —C(═O)OR; —C(═O)NH 2 ; —C(═O)NHR; —C(═O)NR 2 ; —C(═O)NR N1 R N2 ; —NH 2 ; —NHR; —NR 2 ; —NR N1 R N2 ; —NHC(═O)H; —NRC(═O)H; —NHC(═O)R; —NRC(═O)R; and —R; wherein each R is independently selected from: unsubstituted aliphatic C 1-6 alkyl; substituted aliphatic C 1-6 alkyl; unsubstituted aliphatic C 2-6 alkenyl; substituted aliphatic C 2-6 alkenyl; unsubstituted C 3-6 cycloalkyl; substituted C 3-6 cycloalkyl; unsubstituted C 6-10 -carboaryl; substituted C 6-10 carboaryl; unsubstituted C 5-10 heteroaryl; substituted C 5-10 heteroaryl; and unsubstituted C 6-10 -carboaryl-C 1-4 alkyl; substituted C 6-10 -carboaryl-C 1-4 alkyl; wherein, in each group —NR N1 R N2 , independently, R N1 and R N2 taken together with the nitrogen atom to which they are attached form a ring having from 3 to 7 ring atoms; each one of R 3NA and R 3NB is independently selected from: —H; unsubstituted aliphatic C 1-6 alkyl; substituted aliphatic C 1-6 alkyl; unsubstituted aliphatic C 2-6 alkenyl; substituted aliphatic C 2-6 alkenyl; unsubstituted C 3-6 cycloalkyl; substituted C 3-6 cycloalkyl; unsubstituted C 6-10 -carboaryl; substituted C 6-10 -carboaryl; unsubstituted C 5-10 heteroaryl; substituted C 5-10 heteroaryl; and unsubstituted C 6-10 -carboaryl-C 1-4 alkyl; substituted C 6-10 -carboaryl-C 1-4 alkyl; or: R 3NA and R 3NB taken together with the nitrogen atom to which they are attached form a ring having from 3 to 7 ring atoms; and wherein the group —NR 7NA R 7NB is the same as the group —NR 3NA R 3NB : and wherein X is one or more anionic counter ions to achieve electrical neutrality; and pharmaceutically acceptable salts, mixed salts, and hydrates-thereof; wherein the therapeutically effective amount of a diaminophenothizine compound orally administered to the subject is selected from the group consisting of (i) a daily total dose of the diaminophenothizine compound orally administered to the subject of 200 mg-400 mg; (ii) a daily total dose of the diaminophenothizine compound orally administered to the subject of 100 mg-400 mg; (iii) in dosage units of about 10, 20, 30, 40, 50, 60, 80, 90, 100, 110, 120, or 130 mg three times a day; and (iv) in dosage units of about 10, 20, 30, 40, 50, 60, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 mg twice a day.