Study of BHV-4157 in Alzheimer's Disease

Summary

Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, were administered orally once daily. Duration of treatment is 48 weeks in double-blind phase. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period. Eligible participants who completed the double-blind treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in an open-label extension (OLE) phase.

Timeline

Start

2018-07-31

Primary completion

2020-12-15

Completion

2021-12-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Troriluzole vs Placebo; p = 0.9809; Least square mean difference 0.0 (95% CI -1.8 to 1.8) NCT03605667 ↗

registry analysis (superiority test); Troriluzole vs Placebo; p = 0.4474; Least square mean difference -0.2 (95% CI -0.8 to 0.3) NCT03605667 ↗

Publications

• Qiu Y, Jacobs DM, Messer K, Salmon DP, Wellington CL, Stukas S, Revta C, Brewer JB, Leger GC, Askew B, Donahue L, Kaplita S, Coric V, Qureshi IA, Feldman HH; Alzheimer's Disease Cooperative Study T2 Protect AD Study Group. Prognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2025 May 2;17(1):97. doi: 10.1186/s13195-025-01745-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Troriluzole	Peptide	280 mg	Oral

Indications