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
Yonsei University
60 participants
Jan 1, 2024
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
Plain Language Summary
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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
AR1005 inhibits sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate.
Matching placebo for AR1005 to be administered BID for 20 weeks
3mg Rivastigmine will be administered BID for both active and placebo groups
Locations(1)
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NCT06537076