Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

NCT06537076 | Recruiting Phase 2

• 1 other identifier: AR1005-KRP2-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lewy Body Dementia

Keywords

Lewy body dementia; DLB

Outcome Measures

Primary Outcomes (1)

• Clinical Dementia Rating-Sum Of Boxes (CDR-SOB) at Week 20

  The CDR-SOB score ranges from 0 to 18, with 0 indicating no dementia symptoms and 18 indicating severe dementia. Higher scores on the CDR-SOB reflect a worse outcome, as they indicate more severe dementia symptoms.

  20 Weeks

Secondary Outcomes (1)

• Change in K-MMSE over 20 weeks

  20 Weeks

Study Arms (2)

Experimental

EXPERIMENTAL

AR1005 50 mg BID will be administered with rivastigmine 3 mg BID for 20 weeks.

Drug: AR1005; Drug: Rivastigmine 3 mg

Placebo

PLACEBO COMPARATOR

Placebo BID will be administered with rivastigmine 3 mg BID for 20 weeks.

Drug: Placebo; Drug: Rivastigmine 3 mg

Interventions

AR1005 DRUG

AR1005 inhibits sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate.

Also known as: Scheduled for future release

Experimental

Placebo DRUG

Matching placebo for AR1005 to be administered BID for 20 weeks

Placebo

Rivastigmine 3 mg DRUG

3mg Rivastigmine will be administered BID for both active and placebo groups

Experimental; Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Required Requirements
• Dementia, defined as cognitive decline that progresses sufficiently to impair normal social and professional functions or daily life
• Defects in attention, enforcement, and space-time capabilities are noticeable in the inspection
• Core clinical features
• variation in cognitive function
• vision
• Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness
• REM sleep behavior disorder

You may not qualify if:

• 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
• ⑪ Patients with genetic problems such as galactose intolerance, lactose-degrading enzyme deficiency, or glucose-galactose absorption disorders

Sponsors & Collaborators

• Yonsei University: lead
• Samjin Pharmaceutical Co., Ltd.: collaborator
• AriBio Co., Ltd.: collaborator

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Appointments and Schedules; Rivastigmine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Byoung Seok Ye, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Lim Lee

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Will be made available after the study is completed.
• Access Criteria: Access will be provided to qualified researchers affiliated with recognized institutions, who have a valid research plan and appropriate ethical approvals.

Locations

KR (1)