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A Randomized, Double-blind, Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
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.
Details
| Lead sponsor | Yonsei University |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 60 |
| Start date | 2024-01-01 |
| Completion | 2025-12 |
Conditions
- Lewy Body Dementia
Interventions
- AR1005
- Placebo
- Rivastigmine 3 mg
Primary outcomes
- Clinical Dementia Rating-Sum Of Boxes (CDR-SOB) at Week 20 — 20 Weeks
The CDR-SOB score ranges from 0 to 18, with 0 indicating no dementia symptoms and 18 indicating severe dementia. Higher scores on the CDR-SOB reflect a worse outcome, as they indicate more severe dementia symptoms.
Countries
South Korea