NCT06537076

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lewy Body Dementia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-08-05
• Last updated: 2024-10-02

Locations

1 site across 1 country: South Korea