A novel approach using transcranial magnetic stimulation (TMS) is showing potential in slowing the progression of Alzheimer's symptoms. The phase 2 clinical trial results, presented at the Clinical Trials in Alzheimer's Disease meeting in Madrid, indicate that TMS, a non-invasive brain stimulation technique, could offer a new avenue for managing the debilitating effects of Alzheimer's disease.
The study, conducted by researchers at Sinaptica and other institutions, involved 32 volunteers aged 56 to 88 diagnosed with Alzheimer's. Participants were followed for 52 weeks, with 18 receiving weekly 20-minute TMS sessions and 14 receiving sham treatments as a control.
Targeting the Brain's Default Mode Network
Researchers focused on the brain's default mode network, a region crucial for storing memories of life events. Using TMS, they identified the precise spot within this network that would benefit most from electrical stimulation. The goal was to enhance neuronal connections and restore activity in areas affected by the disease.
Dr. Giacomo Koch, a professor of human physiology at the University of Ferrara and co-founder of Sinaptica, explained, "The goal is to restore connections between neurons by enhancing activity in certain areas relevant to the disease. This therapy is like training for the neurons."
Promising Results in Symptom Management
The results showed that patients receiving TMS therapy experienced a 44% slower rate of symptom worsening compared to the sham treatment group. Moreover, the TMS group exhibited minimal decline in their ability to perform daily living activities, a critical factor for both patients and caregivers.
Comparison with Existing Treatments
While current Alzheimer's medications like lecanemab and donanemab have demonstrated a slowing of cognitive decline by 27.1% and 22.3% respectively, these treatments are costly (between $26,500 and $32,000 per patient per year) and carry risks of brain swelling and microhemorrhages. TMS offers a potentially safer and equally effective alternative.
Safety and Tolerability
Side effects associated with TMS were uncommon and generally mild, including headaches, skin discomfort, and neck pain. The non-invasive nature of TMS, using magnetic fields to induce electrical currents in the brain, makes it a well-tolerated option.
Expert Perspectives and Future Directions
Dr. Irina Skylar-Scott, a cognitive neurologist at Stanford University's Center for Memory Disorders, noted the promise of this approach, stating, "As a field we are all excited about novel mechanisms and novel pathophysiological targets."
However, experts also caution that the study's small size and single-center design necessitate further investigation. Dr. Lawrence Honig, a professor of neurology at Columbia University Irving Medical Center, emphasized the need for a multicenter trial to ensure generalizability and the inclusion of biomarker measurements to assess actual improvements in the disease.
Sinaptica is currently planning a phase 3 trial to validate these findings and seek FDA approval for TMS as a treatment for Alzheimer's disease.
