Methods of treating parkinson's disease and/or lewy body disease or disorder(s)
The present disclosure relates to a method of treating Parkinson's Disease and/or Lewy body disease or disorder(s), including Parkinson's disease dementia and dementia with Lewy bodies, comprising administering to a subject ATH-1017.
1. A method of treating Parkinson's disease (PD) and/or Lewy body disease or disorder(s) (LBD), comprising administering to a patient in need thereof 40 or 70 mg per day of a compound of formula A19
or a pharmaceutically acceptable salt thereof for 26 weeks or more; wherein the patient is acetylcholinesterase inhibitor (AChEI) naive or received an AChEI in the past and discontinued AChEI therapy at least 4 weeks prior to administration of the compound.
2. The method of claim 1 , wherein the treating comprises improving one or more symptoms of a motor disorder.
3. The method of claim 1 , wherein the patient has been diagnosed with Parkinson's disease dementia (PDD).
4. The method of claim 1 , wherein the patient has been diagnosed with Lewy body disease or disorder(s) (LBD).
5. The method of claim 1 , wherein the patient is between age 40 and 85.
6. The method of claim 1 , wherein the patient is at Hoehn-Yahr stage 1 to 4.
7. The method of claim 1 , wherein the compound of formula A19 or the pharmaceutically acceptable salt thereof is administered by subcutaneous injection.
8. The method of claim 1 , which slows the decline in the ability to perform activities of daily living and verbal fluency in the patient or improves the ability to perform activities of daily living and verbal fluency in the patient.
9. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves a 13-item Alzheimer's Disease Assessment Scale—cognitive subscale (ADAS-Cog13) score.
10. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves a Clinician Global Impression of Change (CGI-C) score or a Clinician Global Impression of Severity (CGI-S) score.
11. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves an Alzheimer's disease cooperative study-activities of daily living, 23-item version (ADCS-ADL23) score.
12. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score.
13. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves a Non-Motor Symptom Scale (NMSS) score.
14. The method of claim 13 , which reduces the rate of decline, stabilizes, or improves a NMSS domain 2 and/or domain 4 score.
15. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves a Mini-Mental State Examination (MMSE) score.
16. The method of claim 1 , which reduces the rate of decline, stabilizes, or improves a motor symptom in the patient.
17. The method of claim 16 , wherein the reduction in the rate of decline, stabilization, or improvement occurs by at least 2 weeks, at least 4 weeks, at least 6 weeks, at least 8 weeks, at least 10 weeks, at least 12 weeks, at least 16 weeks, at least 18 weeks, at least 20 weeks, at least 22 weeks, at least 24 weeks, or at least 26 weeks after the start of treatment.
18. The method of claim 1 , comprising administering a monosodium salt of the compound of formula A19.
19. The method of claim 1 , comprising administering to the patient in need thereof 40 mg per day of the compound of formula A19, or a pharmaceutically acceptable salt thereof.
20. The method of claim 7 , comprising administering to the patient in need thereof 40 mg per day of the compound of formula A19, or a pharmaceutically acceptable salt thereof.
21. The method of claim 9 , comprising administering to the patient in need thereof 40 mg per day of the compound of formula A19, or a pharmaceutically acceptable salt thereof.
22. The method of claim 1 , wherein the patient has been diagnosed with probable idiopathic Parkinson's disease, or probable LBD.