Researchers in the U.S. and Canada launched a clinical trial evaluating the safety and efficacy of deep-brain stimulation in treatment of mild Alzheimer’s disease.
The study will enroll 20 people aged 55-80 with Medtronic’s (NYSE:MDT) deep brain stimulation technology, surgically implanted devices that are similar to a cardiac pacemaker and that deliver electrical pulses to targeted areas of the brain.
The trial, conducted by Functional Neuromodulation Ltd., will use Medtronic’s DBS therapy to target a specific area considered a "major inflow and output pathway in the brain’s memory circuit," according to a press release.
Each patient in the study, dubbed the ADvance trial, will receive the implant. Researchers will compare the effects of the implant turned on and turned off in a randomized, double-blind manner for a follow-up period of 12 months, according to the report. After the follow-up period patients with the device turned off may elect to flip the switch and activate their implants.
"As people are increasingly aware, there is an urgent need for new and better ways to treat Alzheimer’s," Functional Neuromodulation co-founder and CEO Dan O’Connell said in prepared remarks. "DBS is a promising new approach that has a successful track record in a number of other brain disorders."
Medtronic helped pioneer DBS therapy, which initially won European regulatory approval in 1995 and FDA approval in 1997. Earlier this year Medtronic enrolled the 1st patient into its Medtronic Registry for Epilepsy, a database tracking the safety, efficacy and quality of life of patients receiving deep-brain stimulation for treatment of drug-resistant epilepsy.
Medtronic’s DBS won CE Mark approval for epileptic patients in the European Union in August 2010, but has yet to gain similar approval in the U.S., where it is under humanitarian device exemption for a number of conditions, including treatment-resistant obsessive-compulsive disorder and advanced Parkinson’s disease.
St. Jude Medical‘s (NYSE:STJ) Libra and LibraXP systems are also cleared for treating symptoms of Parkinson’s. The medical device giant is also investigating DBS in treatment of severe depression through its BROADEN trial, building on previous St. Jude work that showed that 62% of patients experienced at least 40% reduction in symptoms of depression at 6 months of treatment. Of those patients, more than 90% maintained the improvement after a year.
