Keck Medicine, of the University of Southern California, Los Angles, USA, is enrolling individuals in an international phase 3 clinical trial to study deep brain stimulation as a treatment for Alzheimer’s disease, sponsored by Functional Neuromodulation.
The clinical trial involves approximately 200 patients at 20 sites across the USA, Canada and Germany. Keck Medicine plans to enrol 8–15 patients.
Electrodes will be implanted into the subjects’ brains, connected to a battery pack which is placed under the collarbone. The study uses electrical impulses through the electrode to stimulate the fornix, and aims at analysing the safety and effectiveness of this as a treatment.
This randomised, double-blind study will last four years, split into two stages. For the first year of the study, subjects’ will receive either low-frequency stimulation, high-frequency stimulation, or no stimulation — to act as placebo.
Based on what is learned in the first year of the trial, for the last three years all of the subjects will receive what has been determined to be the most effective level of stimulation.
The effectiveness of this treatment will be measured with cognitive tests to assess any improvements in memory and learning abilities.
To qualify for the trial patients must be at least 65, have been diagnosed with mild Alzheimer’s and take Alzheimer’s medication, and have a caregiver or family member who can take them to doctor visits.