ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Summary

This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.

Timeline

Start

2020-09-28

Primary completion

2024-07-15

Completion

2024-07-15

Outcome

Missed primary endpoint

release “アルツハイマー病 (ATH-1017,米国第Ⅱ/Ⅲ相) ※P2はprimary未達、sub-analysisで良好な結果 (June 2022)” kringle-pharma.com ↗

release “LIFT-AD trial did not meet primary endpoint of GST and key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23)” leonabio.com ↗

Publications

• Background McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
• Reda SM, Setti SE, Berthiaume AA, Wu W, Taylor RW, Johnston JL, Stein LR, Moebius HJ, Church KJ. Fosgonimeton attenuates amyloid-beta toxicity in preclinical models of Alzheimer's disease. Neurotherapeutics. 2024 Jul;21(4):e00350. doi: 10.1016/j.neurot.2024.e00350. Epub 2024 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fosgonimeton	Small molecule	40 mg	Subcutaneous

Indications