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 study are fully understood and agreed
• •* Total score of 26 points or less in the simplified mental health assessment (K-MMSE)
• •* Dementia Clinical Evaluation Scale (CDR) Total score of 0.5 or higher
• •* Medical history, neurological examination, hematologic examination, Seoul neuropsychological examination 2nd edition, brain magnetic resonance imaging suspected of cognitive impairment due to dementia with Lewy bodies as the cause of cognitive decline
• •i. Lewy body dementia
• •1. In accordance with the guidelines for the 4th report of the Dementia with Lewy Bodies Consortium (DLBC) published in 2017, if it falls under Probable Dementia with Lewy Bodies
• •2. Required Requirements
• •1. Dementia, defined as cognitive decline that progresses sufficiently to impair normal social and professional functions or daily life
• •2. Defects in attention, enforcement, and space-time capabilities are noticeable in the inspection
• •3. Core clinical features
• •1. variation in cognitive function
• •2. vision
• •3. Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness
• •4. REM sleep behavior disorder
• •4. Indicative biomarker
• •1. Decreased intake of dopamine carrier PET-phase nuclear
• •2. \[I-123\]-MIBG myocardial scintigraphy intake decreased
• •3. REM sleep behavior disorder according to polymorphic test
• •5. In the case of two or more key aspects, or one or more key clinical features and one or more indicative biomarkers are satisfied
• •ii. Bulb Lewy body dementia (Prodromal DLB)
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• •1. If it falls under the Probable MCI-LB with a mild cognitive impairment according to the criteria for diagnosing precursor Lewy body dementia announced in 2020
• •2. 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, it should be mainly related to the deterioration of execution function and space-time ability)
• •3. Core clinical features
• •1. variation in cognitive function
• •2. vision (nap, dazed, same document, angry)
• •3. Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness
• •4. REM sleep behavior disorder
• •4. Indicative biomarker
• •a. Decreased intake of dopamine carrier PET-phase nuclear b. \[I-123\]-MIBG myocardial scintigraphy intake decreased c. REM sleep behavior disorder according to polymorphic test
• •5. The leading mild cognitive impairment due to dementia with Lewy bodies has two or more key features or satisfies one or more key clinical features and one or more indicative biomarkers
• •⑥ Patients with caregivers who are in regular contact with the subject (Note: caregivers may support the subject during the clinical trial \[compliance supervision and reporting of the subject's status\], defined as those who spend 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, language skills, motor skills, and comprehension to follow the examination procedure as judged by the tester (Aids such as glasses and hearing aids are allowed)
• •⑨ an examination Patients who have voluntarily decided to participate in this clinical trial and obtained the consent of the subject in writing from both the subject and the subject's legal representative (where written consent is not available, the tester shall keep a record of the matters that the subject has verbally agreed to participate in the trial)