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Safety and Efficacy of AR1005 in Patients with Lewy Body Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

A Randomized, Double-blind, Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

NCT06537076•Yonsei University

View on ClinicalTrials.gov

Summary

This study is a phase 2a, single-center, double-blind and randomized clinical trial that evaluates the safety and efficacy of AR1005 administration in 60 patients with cognitive impairment due to Lewy body disease. The study evaluates whether the administration of AR1005 in patients with cognitive impairment due to Lewy body disease has the effect of improving cognitive function, behavioral psychological symptoms, cognitive fluctuations, movement, brain waves and brain activity.

Detailed Description

60 patients will be randomized into either active or placebo groups (1:1). Both groups will concurrently receive standard treatment with rivastigmine for 20 weeks.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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
+27 more criteria

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 cerebral infraction, and Wernicke's encephalopathy are suspected
•* Subjects who are or are suspected of having an irritable allergy to AR1005-KRP2-01
•* If you are already on antistatic medication
•* A person who cannot perform a brain magnetic resonance image (but if there is a brain magnetic resonance image taken within one year, the brain magnetic resonance image can be omitted)
•* voluntary Employees directly involved in this clinical study or their immediate family members who find it difficult to participate
•* If there is a history of psychiatric disorders: major effective disorder, schizophrenia, schizo-effective disorder
•⑦ If an electroencephalogram cannot be performed
•⑧ Patients who are already taking acetylcholinesterase inhibitor (donepezil and rivastigmine) or taking it in patch form (but can change to rivastigmine PO to participate in the study)
•⑨ Patients with moderate to severe liver disorder (Child-Pugh grade B) and dialysis due to decreased renal functiona patient with end-stage renal impairment receiving
•⑩ Patients discontinued administration due to aseptic meningitis associated with AR1005-KRP2-01
+1 more criteria

Locations (1)

Severance Hospital

Seoul, South Korea

Key Dates

Start Date

January 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

October 2, 2024

Enrollment

ESTIMATED participants

Conditions

Lewy Body Dementia

Interventions

AR1005

DRUG

Placebo

DRUG

Rivastigmine 3 mg

DRUG

Contacts

Jung Lim Lee

CONTACT

+82-2-2227-7716 jll2024@yuhs.ac

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

Inclusion Criteria

Exclusion Criteria

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