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RECRUITING
NCT06537076
PHASE2

Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

Sponsor: 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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-01-01

Completion Date

2025-12

Last Updated

2024-10-02

Healthy Volunteers

No

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

Locations (1)

Severance Hospital

Seoul, South Korea