Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

Phase 2 Completed 210 enrolled AriBio Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.

Timeline

Start: 2019-04-01
Primary completion: 2020-12-22
Completion: 2021-06-28

Publications

Greeley D, Nash M, Herskowitz B, Kim F, Rock J, Prins N, Kim S, Xi T, Busam JA, Tete B, Choung JJ, Sha SJ. A phase 2 randomized, placebo-controlled study on the efficacy and safety of AR1001, a phosphodiesterase-5 inhibitor, in patients with mild-to-moderate Alzheimer's disease. J Prev Alzheimers Dis. 2025 Nov;12(9):100337. doi: 10.1016/j.tjpad.2025.100337. Epub 2025 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	AR1001	Small molecule	10 mg	Oral
Comparator	AR1001	Small molecule	30 mg	Oral

Indications

No indication recorded.