Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

Inclusion Criteria:

• men and women over the age of 60

• Communication in Korean is possible and the purpose and process of the studyare fully understood and agreed

• Total score of 26 points or less in the simplified mental healthassessment (K-MMSE)

• Dementia Clinical Evaluation Scale (CDR) Total score of 0.5 or higher

• Medical history, neurological examination, hematologicexamination, Seoul neuropsychological examination 2nd edition,brain magnetic resonance imaging suspected of cognitiveimpairment due to dementia with Lewy bodies as the cause ofcognitive decline i. Lewy body dementia

1. In accordance with the guidelines for the 4th report of theDementia with Lewy Bodies Consortium (DLBC) published in 2017, if it falls under Probable Dementia with Lewy Bodies

2. Required Requirements

3. Dementia, defined as cognitive decline that progressessufficiently to impair normal social and professionalfunctions or daily life

4. Defects in attention, enforcement, and space-timecapabilities are noticeable in the inspection

5. Core clinical features

6. variation in cognitive function

7. vision

8. Parkinson's syndrome: One or more manifestations ofsinusitis, stable progress, or stiffness

9. REM sleep behavior disorder

10. Indicative biomarker

11. Decreased intake of dopamine carrier PET-phase nuclear

12. [I-123]-MIBG myocardial scintigraphy intake decreased

13. REM sleep behavior disorder according to polymorphictest

14. In the case of two or more key aspects, or one or more keyclinical features and one or more indicative biomarkers aresatisfied ii. Bulb Lewy body dementia (Prodromal DLB)

15. If it falls under the Probable MCI-LB with a mild cognitiveimpairment according to the criteria for diagnosingprecursor Lewy body dementia announced in 2020

16. Required Requirements a. cognitive decline observed when judged by the patient,guardian, or clinician b. Objective cognitive decline (although it is not related to any cognitive domain, itshould be mainly related to the deterioration of executionfunction and space-time ability)

17. Core clinical features

18. variation in cognitive function

19. vision (nap, dazed, same document, angry)

20. Parkinson's syndrome: One or more manifestations ofsinusitis, stable progress, or stiffness

21. REM sleep behavior disorder

22. Indicative biomarker a. Decreased intake of dopamine carrier PET-phase nuclearb. [I-123]-MIBG myocardial scintigraphy intake decreased c.REM sleep behavior disorder according to polymorphic test

23. The leading mild cognitive impairment due to dementia withLewy bodies has two or more key features or satisfies oneor more key clinical features and one or more indicativebiomarkers ⑥ Patients with caregivers who are in regular contact withthe subject (Note: caregivers may support the subjectduring the clinical trial [compliance supervision andreporting of the subject's status], defined as those whospend at least 8 hours per week with the subject) ⑦ Patients who can walk or move with walking aids (i.e.,walkers, canes, or wheelchairs) ⑧ Patients with sufficient vision, hearing, languageskills, motor skills, and comprehension to follow theexamination procedure as judged by the tester (Aids such asglasses and hearing aids are allowed) ⑨ an examination Patients who have voluntarily decided toparticipate in this clinical trial and obtained the consentof the subject in writing from both the subject and thesubject's legal representative (where written consent isnot available, the tester shall keep a record of thematters that the subject has verbally agreed to participatein the trial)

Exclusion Criteria:

• In hematologic and brain magnetic resonance imaging tests conducted within 6 months,other causes of cognitive decline such as neurosyphilis, hypo/hyper-throidism,metabolic encephalopathy, brain tumor, acute cerebral hemorrhage, acute cerebralinfraction, and Wernicke's encephalopathy are suspected

• Subjects who are or are suspected of having an irritable allergy toAR1005-KRP2-01

• If you are already on antistatic medication

• A person who cannot perform a brain magnetic resonance image (but ifthere is a brain magnetic resonance image taken within one year, thebrain magnetic resonance image can be omitted)

• voluntary Employees directly involved in this clinical study ortheir immediate family members who find it difficult toparticipate

• If there is a history of psychiatric disorders: majoreffective disorder, schizophrenia, schizo-effectivedisorder ⑦ If an electroencephalogram cannot be performed ⑧ Patients who are already taking acetylcholinesteraseinhibitor (donepezil and rivastigmine) or taking it inpatch form (but can change to rivastigmine PO toparticipate in the study) ⑨ Patients with moderate to severe liver disorder (Child-Pugh grade B) and dialysis due to decreased renalfunctiona patient with end-stage renal impairment receiving ⑩ Patients discontinued administration due to asepticmeningitis associated with AR1005-KRP2-01 ⑪ Patients with genetic problems such as galactoseintolerance, lactose-degrading enzyme deficiency, orglucose-galactose absorption disorders