Sinaptica Therapeutics Inc. received a U.S. FDA breakthrough device designation for its electromagnetic therapy for Alzheimer’s disease. Sinaptistim-AD combines neurostimulation, brain wave monitoring, and artificial intelligence (AI) to address the cognitive and functional decline in patients with neurological disorders.
“We are excited that the FDA has recognized the groundbreaking potential of our SinaptiStim–AD System with breakthrough device designation,” said Rich Macary, president of Sinaptica Therapeutics. “This marks an important milestone for the company, as it helps establish our regulatory pathway for FDA clearance of our Sinaptistim–AD system. We look forward to collaborating with the agency to address the significant unmet need in the treatment of Alzheimer’s disease by developing a novel, safe, effective, non-invasive and personalized electromagnetic therapeutic for patients.”
The system uses transcranial magnetic stimulation (TMS) with electroencephalogram (EEG) to monitor the full spectrum of brain waves in specific networks of the brain and the connectivity of additional networks and regions, Macary told BioWorld.
While a number of other companies have employed TMS for a range of neurological conditions, including depression and anxiety, Sinaptica’s differs by offering very customized therapy that targets the networks affected by Alzheimer’s disease.
“We are using our AI-derived personalization engine to ingest patient-specific data including TMS/EEG data and brain imaging. Based on this information, multiple parameters are modified for that patient and a personalized treatment protocol is determined and delivered.” Macary said. “It is this ability to personalize and precision deliver to a specific network in the brain that has provided both a high response rate and clinical efficacy.”
The need for new approaches to treatment
A treatment for Alzheimer’s disease that could reverse cognitive impairment and preserve independence and functionality would be transformative for the 6 million Americans with the disease and for the Cambridge, Mass. based company. Characterized by changes in memory, reasoning, behavior and thought, Alzheimer’s can ultimately deprive patients of their history, personalities, autonomy and life.
While typically a disease of the old, Alzheimer’s is not a normal part of aging, but a neurological disorder that researchers are still struggling to fully understand as the physical hallmarks, amyloid beta plaques, and tau tangles, appear to have a complex relationship with development of the disease.
What is clear, however, is that changes in the brain often begin decades before symptoms manifest. Exercise and social engagement have shown some effectiveness in slowing and reversing progression. Pharmacotherapies remain controversial with limited benefit and significant risks of brain hemorrhage. Alternatives are urgently needed.
Sinaptica hopes to provide another option soon. “We plan to continue working toward the initiation of our pivotal trial next year, as well as further advancing the emerging field of electromagnetic therapeutics given their unique ability to modulate key mechanisms of synaptic plasticity and network connectivity in targeted regions of the brain,” said Macary.
Addressing synaptic plasticity holds promise, as it is “considered to be one of the most important neurological mechanisms being altered in the brains of Alzheimer’s patients,” the company said. “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.”
Similarly, disruptions between and within brain networks also appear to be critical change that leads to symptoms in Alzheimer’s patients, making restoration of their normal function another potential target for therapies. “At early clinical stages of the disease, synaptic dysfunction and disconnection of the [default mode network] DMN precedes and contributes to the occurrence of regional brain atrophy and protein accumulation including amyloid and tau,” the company noted. DMN can be targeted by electromagnetic brain stimulation, improving both plasticity and network stability. Sinaptica’s system aims to improve both plasticity and network function.
“The randomized, double-blind placebo/sham-controlled phase II study we shared with the FDA is currently pending publication in a peer-reviewed journal,” Macary noted. “We expect the paper to be made public imminently.”
The company is also exploring whether the same technology may help reverse mild cognitive impairment, often the first symptom of Alzheimer’s disease and other dementias.
Sinaptica Therapeutics was co-founded by two researchers and clinicians in the fields of neurology and electrophysiology: Giacomo Koch, professor of physiology at the University of Ferrara, Italy, and director, Non-invasive Brain Stimulation Laboratory, at Santa Lucia Foundation in Rome, and Emiliano Santarnecchi, associate professor of radiology at Harvard Medical School and director, Precision Neuroscience & Neuromodulation Program at Boston’s Massachusetts General Hospital.
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