Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

Summary

The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC. The secondary objectives are: * To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events. * To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).

Timeline

Start

2014-03

Primary completion

2017-05-05

Completion

2017-05-05

Outcome

Missed primary endpoint

registry analysis (superiority test); T-817MA-H vs Placebo; p = 0.3919; Mean Difference (Final Values) -0.84 NCT02079909 ↗

registry analysis (superiority test); T-817MA-H vs Placebo; p = 0.7588; Mean Difference (Final Values) 0.04 NCT02079909 ↗

Publications

• Schneider LS, Thomas RG, Hendrix S, Rissman RA, Brewer JB, Salmon DP, Oltersdorf T, Okuda T, Feldman HH; Alzheimer's Disease Cooperative Study TCAD Study Group. Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2019 Nov 1;76(11):1330-1339. doi: 10.1001/jamaneurol.2019.1868.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	edonerpic	Unknown	224 mg	—
Subject	edonerpic	Unknown	448 mg	—

Indications