Phase 2/3 Clinical Trial of Trigriluzole for Alzheimer's Disease Initiated
A Phase 2/3 clinical trial of trigriluzole (BHV-4157; Biohaven, Cambridge, MA for treatment of patients with mild-to-moderate Alzheimer's disease (AD) has been initiated in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), and the first patient with AD is expected to enroll in the coming weeks.
The phase 2/3 clinical trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with mild-to-moderate AD, defined as having a Mini-Mental State Examination score between 14 and 24 at initial screening. Patients who have been taking stable doses of acetylcholinesterase inhibitors (AchEI) and/or memantine for at least three months prior to screening and who are willing to remain on the same regimen for the duration of the trial may be eligible to participate. The study aims to enroll 292 patients who will be randomized on a 1:1 basis to receive 280 mg of trigriluzole or placebo, taken orally at bedtime for 48 weeks.
Trigriluzole is a novel therapeutic approach aimed at normalizing synaptic and extrasynaptic glutamate levels, that may symptomatic benefit for persons with AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses. It is believed that trigriluzole may work by reduce presynaptic glutamate, increasing uptake by glial cells, enhancing glutamatergic signal transmission, altering GABAergic neurotransmission, or affecting neurotrophins, thus offering neuroprotective effects at the level of the synapse as well as improved synaptic functioning. These mechanisms that could have both symptomatic and disease-modifying effects.