MedTrace Logo

Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

NCT06537076 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-02

No results posted yet for this study

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

Interventions

DRUG

AR1005

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

DRUG

Placebo

Matching placebo for AR1005 to be administered BID for 20 weeks

DRUG

Rivastigmine 3 mg

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

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • AriBio Co., Ltd.

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Byoung Seok Ye, MD, PhD · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06537076 on ClinicalTrials.gov