Maybe the way we have been trying to treat Alzheimer’s disease has been all wrong? Ken Mariash, the CEO at Synaptica Therapeutics, thinks so. And the lack of compelling treatments thus far, confirms it. For decades the focal point of treating Alzheimer’s, a disease that affects millions worldwide, has been the reduction of amyloid plaque. Amyloid plaques are clumps of misfolded proteins, specifically beta-amyloid, that accumulate in the spaces between nerve cells in the brain. Patients with Alzheimer’s have a buildup of this substance that impacts the communication between neurons. Scientists have theorized that since this build-up of plaque is a cause of Alzheimer’s then getting rid of the plaque will lead to a cure. But to date, none of these treatments have worked very well. Ken and his team believe that they have a better approach.
Sinaptica Therapeutics, an emerging biotechnology startup, is advancing an exciting new paradigm for treating cognitive decline, positing that conditions like Alzheimer’s disease stem from a neuronal circuit deficiencies rather than solely from established biochemical factors such as amyloid plaque. They theorize that the fundamental pathology lies at the synaptic and functional network level. Sinaptica is currently testing a proprietary, non-invasive neuromodulation technique that utilizes precisely targeted magnetic signaling to enhance and regulate the electrical currents between synapses. The goal is to stimulate neuroplasticity and restore healthy neural network function, leading the way in personalized therapeutic approaches through ongoing clinical trials.
Targeted Therapy Treating the Default Mode Network
Sinaptica’s SinaptiStim™ – AD System delivers EEG- and MRI-guided electromagnetic brain stimulation, precisely targeting the Default Mode Network (DFM) — a key network impacted in Alzheimer’s. The DFM works behind the scenes in our brain, activating when we are not involved in specific task related thoughts. The DFM may help us with storing memories. A normal functioning Default Mode Network sends neural signals between regions of the brain from the medial prefrontal cortex, to the posterior cingulate cortex, precuneus, and angular gyrus. An Alzheimer’s patient has more limited (or non-existent) signaling across these areas of the brain.
Using artificial intelligence, and targeted information for each individual, treatment patterns are optimized for each patient, ensuring personalized neuromodulation that complements existing therapies. The patients come in for weekly treatments that take about 25 minutes each. This approach differs from traditional Alzheimer’s medications by being non-invasive, device-based, and patient-specific, providing a promising alternative or adjunct to standard care.
The Breakthrough We have Been Hoping for?
In a 52-week Phase 2 clinical trial, patients treated with Sinaptica’s system experienced slowed cognitive decline and maintained daily functioning compared to a control group who did not receive the treatment. Functional measures for patients remained nearly unchanged, surpassing what would normally be expected by Alzheimer’s disease progression. These remarkable positive outcomes contributed to Sinaptica being awarded FDA Breakthrough Device Designation, emphasizing the therapy’s potential in real-world treatment.
This clinical trial highlights the incredible potential of personalized neuromodulation in treating cognitive disorders. By combining cutting-edge technology, AI-guided precision, and clinical expertise, Sinaptica Therapeutics is working on a therapy to help patients preserve their quality of life and offering new opportunities for clinicians and researchers in the Alzheimer’s space.
As Sinaptica Therapeutics pushes forward with its phase 3 clinical trials, the potential impact is monumental: patients might not only see the disease progression slowed but could potentially maintain their critical daily functions. This represents a truly significant leap in the fight against Alzheimer’s. By championing this innovative approach—using magnetic signaling to boost the brain’s natural ability to rewire itself (neuroplasticity)—Sinaptica is demonstrating that fresh thinking in clinical research can fundamentally transform the future of neurodegenerative disease care. And other companies are paying attention, bringing similar non-invasive, neuromodulation treatments forward. Could these groundbreaking, non-invasive methods finally be the key we’ve been searching for to unlock a cure?