RecruitingPhase 2NCT06537076

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


Sponsor

Yonsei University

Enrollment

60 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AR1005, a drug called Placebo, and others for people with lewy body dementia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAR1005

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

DRUGPlacebo

Matching placebo for AR1005 to be administered BID for 20 weeks

DRUGRivastigmine 3 mg

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


Locations(1)

Severance Hospital

Seoul, South Korea

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NCT06537076


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