Results from the investigator-sponsored trial of SonoCloud in patients with mild Alzheimer’s Disease (AD) were published this week in the Alzheimer’s Research & Therapy Journal.
Paris-based Carthera designed SonoCloud, an implantable 1 MHz ultrasound device, to be activated on-demand using a transdermal needle connected to an external interface. The company said in a news release that the platform, which delivers low-intensity pulsed ultrasound (LIPU) to temporarily disrupt the blood-brain barrier (BBB), reduced β-amyloid and tau pathologies and improved cognitive performance in Alzheimer’s preclinical models.
Professor Alexandre Carpentier and Dr. Stéphane Epelbaum conducted a translational study at Hôpital de la Pitié-Salpêtrière (AP-HP Sorbonne, Paris, France) that follows previous trials displaying Sonocloud’s potential. The aim of the study was to demonstrate the safety of the technology in patients with mild AD, as well as to explore whether ultrasound alone could reduce their amyloid load.
In the trial, patients with mild AD had a single-emitter version of the SonoCloud implanted under local anesthesia to target the left supramarginal gyrus. Seven ultrasound sessions — lasting approximately 10 minutes each — over three and a half months were performed twice per month on nine patients to temporarily disrupt the BBB.
PET imaging was performed at inclusion and at four and eight months after initial sonications to monitor brain metabolism and amyloid levels. The trial showed that SonoCloud can disrupt the BBB in Alzheimer’s patients and it further confirmed the safety previously demonstrated in patients with brain tumors.
Additionally, researchers observed a slight decrease in amyloid load in the majority of patients despite the short treatment and observation window, which Carthera said demonstrates the therapeutic potential of the modality previously observed in preclinical models.
“We’re currently planning a clinical trial that will lead to marketing authorization of the SonoCloud for the treatment of glioblastoma while also continuing to explore this technology in a greater number of brain indications in combination with various therapeutic agents,” Carthera CEO Frédéric Sottilini said in the release. “The outcomes of this study reinforce our conviction that the SonoCloud has the potential to unlock the efficacy of therapies for brain diseases that were previously untreatable.”