- Carthera has announced the publication of clinical trial results from its first study in patients with Alzheimer’s disease.
- Nine participants underwent blood-brain barrier opening of the supra-marginal gyrus region of the brain twice per month for 3.5 months.
- The procedure was safe and well tolerated.
Carthera, a French therapeutic ultrasound device manufacturer that has been successful in testing its SonoCloud device for the treatment of glioblastoma, has announced the publication of clinical trial results from its first study in patients with Alzheimer’s disease.
Professor Alexandre Carpentier, MD, and Dr. Stéphane Epelbaum conducted the translational study (NCT 03119961) in nine participants at Hôpital de la Pitié-Salpêtrière in Paris. In the trial, participants with early-stage Alzheimer’s were implanted with a 1-MHz SonoCloud-1 device then received seven treatment sessions over 3.5 months (twice per month) to temporarily disrupt the blood-brain barrier (BBB). The targeted brain region was the left supra-marginal gyrus.
The data and study parameters are described in “Pilot Study of Repeated Blood-Brain Barrier Disruption in Patients with Mild Alzheimer’s Disease with an Implantable Ultrasound Device,” which was published in the journal Alzheimer’s Research and Therapy.
The research team deemed the procedure to be safe and well-tolerated, and they found a slight decrease in amyloid accumulation in the targeted region. The decrease in accumulation was found in six of the participants and not statistically significant in the short duration of the study.
“The study’s findings complement the promising results already published and confirm the significant role that the SonoCloud device can play in the treatment of a wide spectrum of brain diseases, particularly if coupled with a novel drug therapy,” said Pr. Carpentier. “Carthera is actively seeking collaborations with pharma partners to further develop this technique and allow a greater number of patients to benefit from this innovative treatment.”
Carthera is planning a larger study to further evaluate whether amyloid accumulation can be reduced with or without the administration of therapeutics.