Sinaptica Therapeutics™ and its co-founders are committed to bringing a safe, effective, and non-invasive electromagnetic therapeutic treatment to Alzheimer’s patients that can help to significantly slow the progression of both cognitive and functional decline. Given the massive toll Alzheimer’s takes on patients, their families and caregivers, our team is working hard toward executing on a pivotal clinical study designed to support our regulatory submission to obtain FDA approval before we can commercialize our Sinaptistim™ AD – System to treat patients in need of safe, proven and effective therapeutic treatments.
Sinaptica Therapeutics™ is a Cambridge MA-based, clinical-stage company that has developed a personalized closed-loop neuromodulation therapy for Alzheimer’s Disease (AD). The company was founded by two top clinical researchers in the field of noninvasive brain modulation for neurodegenerative disorders, together with support from biotech, digital health, and medical device industry executives. The company’s SinaptiStim™ system represents a totally new approach to treating AD by enhancing neuroplasticity via neurostimulation of key brain networks involved in memory, and has been granted FDA Breakthrough Designation based on unprecedented published Phase 2 sham-controlled data that achieved statistical significance on all four gold-standard cognitive & functional clinical endpoints.
Sinaptica is building upon over a decade of research on innovative brain targeting methods, biophysical modeling, and noninvasive treatment protocols leveraging machine learning on proprietary datasets to create a foundational leap in personalized precision electromagnetic therapeutics. Based on highly significant published sham-controlled data, the company's neurostimulation device and integrated personalization engine has the potential to become one of the most clinically-effective treatments to reach Alzheimer’s patients in over two decades, and is protected by multiple pending patents.
Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks. People with Alzheimer’s also experience changes in behavior and personality. According to the Alzheimer’s Association, more than 6 million Americans, many of them age 65 and older, are estimated to have Alzheimer’s disease in 2022. That’s more individuals living with Alzheimer’s disease than the population of a large American city. Many more people experience Alzheimer's in their lives as family members and friends of those with the disease.
The hallmarks of Alzheimer’s disease — changes in thinking, remembering, reasoning, and behavior - progress during a few years and lead to dementia. That’s why Alzheimer’s is sometimes referred to as “dementia.” Other diseases and conditions can also cause dementia, with Alzheimer’s being the most common cause of dementia in older adults. Alzheimer’s disease is not a normal part of aging. It’s the result of complex changes in the brain that start some 20 years before symptoms appear and lead to the loss of brain cells and their connections. Currently, there are no approved or available disease modifying treatments that have been proven to be clinically effective in slowing the progression of cognitive and functional decline associated with Alzheimer’s disease.
The pharmaceutical industry has been focused for nearly two decades on the pathological targets of Alzheimer’s, such as the accumulation of proteins in the brain, with the most common targets being amyloid beta and tau protein. However, these attempts have historically fallen short in the clinic, although more recently amyloid clearing drug candidates have demonstrated some ability to slow down the progression of the disease, mostly for patients at the earliest stages of Alzheimer’s or experiencing mild cognitive impairment (MCI). Moving beyond the potential impact of drugs that can clear proteins such as amyloid and their associated risks, synaptic plasticity, which is the foundation of learning and memory, is considered to be one of the most important neurological mechanisms being altered in the brains of Alzheimer’s patients. Damage and disruption to synaptic plasticity, which is defined as the ability of synapses to strengthen or weaken over time in response to increases or decreases in their activity, has increasingly been recognized as a hallmark of Alzheimer’s disease. Ultimately the various pathological processes of the disease, which are still not fully understood, all lead to synaptic disfunction and damage. Thus targeting and improving synaptic plasticity represents an attractive therapeutic strategy.
In parallel and related to synaptic damage and disruption, strong evidence has emerged regarding the dysregulation of brain networks in Alzheimer’s patients over the past decade, suggesting the restoration of normal network activity and connectivity as another promising therapeutic target. More specifically, Alzheimer’s disease patients develop alterations of the so-called Default Mode Network (DMN), a key network responsible for episodic memory for which the Precuneus is a key brain region. At early clinical stages of the disease, synaptic dysfunction and disconnection of the DMN precedes and contributes to the occurrence of regional brain atrophy and protein accumulation including amyloid and tau. This means that the DMN is an important as well as a vulnerable region in the transitional stages towards dementia. Fortunately, the DMN can be targeted by personalized and precision delivered non-invasive therapeutic interventions that utilize electromagnetic brain stimulation to both improve plasticity and stabilize the network connectivity.
In this context, precision delivered, personalized non-invasive brain stimulation methods have the potential to be a novel approach to improve cognitive function in patients with dementia by enhancing cortical plasticity and modulating network activity. The co-founders of Sinaptica, leading scientists in the field of neurodegenerative diseases as well as electrophysiology and neuromodulation, have a combined 30 years of research experience on synaptic dysfunction as well as the study of disrupted network activity in the brain. By using novel brain targeting techniques combined with proprietary algorithms and precision delivery of a personalized electromagnetic therapeutic, the co-founders have conducted clinical studies in patients with AD, which yielded promising data that supported FDA’s grant of the Breakthrough Device Designation for the Sinaptistim™ AD – System.
The SinaptiStim™ - AD System is for investigational use only. It has not been approved by the Food and Drug Administration and is not available for commercial sale.
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