What is the target of Sinaptica's new technique within the brain, and how does it aim to combat the effects of Alzheimer's disease?
Our new Alzheimer’s treatment, which has completed a Phase 2 trial, is based on precision non-invasive brain stimulation, using high-powered magnetic fields to induce electrical currents in the brain. The technology is well-established in treating other areas of the brain involving depression; however, our approach specifically targets the brain’s Default Mode Network (DMN), which plays a crucial role in episodic memory and is significantly impacted in Alzheimer’s. Our personalized approach induces neuroplasticity across this network, strengthening its connections and countering Alzheimer's pathology, dramatically slowing the progression of the disease.
Why is personalization so important? How does integrating EEG (electroencephalography) with your therapy enhance its precision and customization for each patient?
Every patient's brain is wired differently and responds differently to stimulation, requiring us to tailor the treatment for each individual patient. By pairing our stimulation technology with EEG, we're able to use single pulses just like active sonar: pinging, then listening for signals that reveal the brain’s connections and patterns, allowing us to find the right target. This important step allows us to maximize engagement of the DMN, and therefore provide the most therapeutic benefits.
Once customized, the therapy is delivered in weekly 25-minute sessions while the patient lies back in a recliner. It is totally safe and painless.
Based on this technology, our co-founders’ Phase 2 study demonstrated an 82% slowing of Alzheimer's progression on the primary endpoint. Similar remarkable efficacy was demonstrated on all relevant secondary endpoints, including activities of daily living (ADLs), where it actually arrested the decline completely at 6 months. These findings represent an unprecedented level of efficacy in Alzheimer's treatment, without the side effects commonly associated with drug-based treatments.
The term "breakthrough" is overused, yet in my two decades of experience in Alzheimer's research, I have never encountered placebo-controlled efficacy data as compelling as what we've observed at Sinaptica.
What has been the immediate reaction to these results in the scientific community and market?
The response has been a mix of surprise, excitement, and astonishment, especially since the field has endured nearly three decades of clinical failures until the very recent approval of two amyloid-clearing drugs. The surprise is that we achieved these spectacular results—not with a drug—but with brain stimulation technology. The excitement comes from the possibility that our therapy could add years—not months—to a patient’s life by significantly slowing the disease.
These reactions have also sparked interest in exploring combinatorial approaches with our therapy, recognizing that tackling Alzheimer's will require multifaceted strategies that could include both devices and drugs. As research advances, the scientific community is starting to acknowledge the limitations of focusing solely on amyloid and tau, recognizing the need for new directions.
Looking ahead, how do you plan to bring this therapy to patients?
We are currently preparing for our larger, multi-center Phase 3 trial, working with the FDA and experts on our Scientific Advisory Board.
Sinaptica has a key advantage over new drugs in development, because our treatment could be approved and available to patients in 3-4 years, instead of the 10+ years required for a new drug to be approved.
We're committed to ensuring our therapy reaches as many patients as possible, especially those with Moderate Alzheimer's who currently have no approved treatment options.
Have you faced skepticism around using neuromodulation to treat Alzheimer's? How do you counter this?
It's all about the rigor and transparency of our science and clinical data. We’re focused on conducting well-controlled studies, publishing in respected journals like the Oxford Journal, Brain [link to publication: https://academic.oup.com/brain/article/145/11/3776/6701823], and adhering to the highest scientific standards, including submitting our clinical data for peer review. Our scientific co-founders come from top institutions (Harvard MGH in Boston and the Santa Lucia Foundation in Rome), have authored over 450 publications between them and are highly regarded in their respective fields. Most importantly, our Phase 2 clinical results are corroborated by electrophysiological measures, fMRI, and MRI, which all indicate that our therapy has a profound, measurable effect on the brain.
What is your vision for Sinaptica's future and its impact on Alzheimer's treatment?
Our focus remains on successfully completing our Phase 3 trial in Alzheimer’s and bringing new hope to patients and their families facing this devastating disease. We believe electrophysiology approaches such as ours that intervene in the complex electrical signaling of the brain are going to become indispensable tools in the treatment of neurodegenerative disease, stroke, traumatic brain injury, and beyond. We’ve seen this play out in the field of cardiology, where electrophysiology has become an important standard.
We see a future where new diagnostics and biomarkers help doctors select the right combination of therapeutics, including both drug and device.
And our long-term vision is to not only address Alzheimer’s, but to help prevent cognitive decline in the first place. Imagine a world where people can go to their neighborhood brain clinics to get regular, non-invasive brain stimulation to maintain their cognitive health and prevent neurodegenerative diseases. This proactive “healthy aging” approach could revolutionize how we think about aging and how we prevent cognitive decline.
