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Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

Study acronym: AR1005
StatusUnknown
PhasePhase 2
Started
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Record status
This record was last updated October 2, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Study Identification, Study Status, Sponsor/Collaborators, Oversight, Arms and Interventions, Contacts/Locations, IPDSharingv3
  3. Interventions: AR1005 (Drug) to AR1005 (Drug), Placebo (Drug), Rivastigmine 3 mg (Drug)
    • Eligibility criteria revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yonsei University
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Dementia
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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.
Trial Details
NCT Number NCT06537076
Lead Sponsor Yonsei University
Collaborators: Samjin Pharmaceutical Co., Ltd., AriBio Co., Ltd.
Conditions
(from sponsor)		 Lewy Body Dementia
Related terms Lewy Body Disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov