Publication in Alzheimer's & Dementia Elucidates Multimodal Mechanism of Action Underpinning Promising New Neuromodulation Therapy for Alzheimer's

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer's and other primary neurodegenerative diseases, today announced that a comprehensive review article published in the peer-reviewed journal Alzheimer's & Dementia: The Journal of the Alzheimer's Association delivers a landmark synthesis of evidence that positions repetitive transcranial magnetic stimulation (rTMS) as a scientifically grounded, non-invasive therapeutic strategy for Alzheimer's disease (AD).
The publication, ' The Neurobiological Foundation of Effective Repetitive Transcranial Magnetic Brain Stimulation in Alzheimer's Disease,' was authored by a multidisciplinary team led by Sinaptica scientific co-founder Dr. Giacomo Koch of the Santa Lucia Foundation, University of Ferrara, and the Italian Institute of Technology. Drawing on foundational models and recent clinical and animal data, the article charts how rTMS modulates biological systems across multiple levels—molecular, cellular, synaptic, and network-wide—to address core mechanisms of neurodegeneration.
'Our goal with this publication is to consolidate the preclinical and clinical findings to explain why rTMS isn't just symptomatic—it is actually disease modifying. This gives us a foundational understanding of how stimulation protocols can directly modulate neurotransmission, reduce inflammation, enhance plasticity, and even promote clearance of toxic proteins,' said Giacomo Koch, MD, PhD, Sinaptica scientific co-founder, Neurologist, Professor of Physiology, University of Ferrara, and Director, Non-Invasive Brain Stimulation Laboratory, Santa Lucia Foundation.
The publication reviews the evidence supporting the fundamental mechanisms of action of rTMS treatments in AD. rTMS exerts profound effects from the micro-molecular scale to the macro network-level scale. By engaging distinct pre- and post-synaptic structures within the stimulated neural network, it directly and indirectly influences various cellular and molecular components. These effects work together to stabilize and improve brain function through the following means:
Strengthens Neuronal Structures - Upregulates neurotrophic factors e.g. BDNF, leading to neuronal structural changes e.g. via remodeling of dendritic spines.
Strengthens Synapses - Modulates neurotransmitter circuits, both through increased production and sensitivity of dopaminergic-, glutamatergic-, and GABA-ergic pathways.
Neuroinflammation - Mitigates neuroinflammation by reducing microglial activation and pro-inflammatory cytokines release e.g. by promoting glutamate reuptake.
Amyloid - May counteract beta amyloid overproduction and toxic aggregation by interrupting a vicious cycle of hyperexcitability.
Tau - Potentially reduces tau hyperphosphorylation and accumulation via the GSK-3β pathway.
Clearance - Potentially increases glymphatic clearance of toxic proteins.
All of the above mechanisms contribute to restoring network-wide excitation/inhibition imbalance, restoring LTP-like mechanisms of neuroplasticity, and enhancing large-scale connectivity.
Authors of this definitive paper are Giacomo Koch (Experimental Neuropsychophysiology Lab, Department of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS), Emiliano Santarnecchi (Gordon Center for Medical Imaging, Mass General Research Institute; Harvard Medical School), Harald Hampel (Sorbonne University, Alzheimer Precision Medicine (APM), AP-HP, Pitié-Salpêtrière Hospital), Annibale Antonioni (Department of Neuroscience and Rehabilitation, University of Ferrara), and Alessandro Martorana (Memory Clinic, Department of Systems Medicine, University of Tor Vergata).
'Based on this new publication, repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus in the brain's central Default Mode Network is an emerging element of precision medicine in neurology. Based on accumulating basic, translational, and clinical evidence, this standardized targeted non-invasive electro-magnetic brain stimulation will likely be part of the evolving clinical care landscape with different treatments and combinations,' said co-author Dr. Harald Hampel, a leading international brain researcher and Alzheimer's disease (AD) scientist. 'Further clinical studies are warranted to benefit the globally increasing population of AD patients.'
As the field moves toward more personalized and mechanistically distinct Alzheimer's therapies, this review provides a vital reference point for researchers, clinicians, and innovators. It supports the integration of rTMS into a precision medicine framework that could transform how providers manage Alzheimer's—potentially shifting the paradigm from reactive care to proactive, highly tailored, connectome-level intervention, including combination therapies.
'We are beginning to see rTMS emerge as a safe, scalable precision medicine platform for Alzheimer's,' said Emiliano Santarnecchi, PhD, co-founder of Sinaptica Therapeutics, Associate Professor of Radiology & Neurology at Harvard Medical School, as well as Director, Precision Neuroscience & Neuromodulation Program and Director, Network Control Laboratory, at Massachusetts General Hospital in Boston, MA. 'This is not just about stimulating the brain—it's about rewiring disease-affected networks with intention and scientific precision.'
The publication establishes the translational relevance of these findings, citing Phase 1 and 2 human trials in which targeted, neuronavigated rTMS protocols have boosted memory, stabilized cognitive performance, restored functional brain connectivity, and enhanced gamma rhythm activity—key markers of brain health. These protocols, particularly those focused on the Default Mode Network (DMN), are seen as promising interventions for mild cognitive impairment and Alzheimer's.
'This definitive reference illuminates an evolving paradigm shift away from simplistic linear 'nerve stimulation' toward the new and rapidly progressing field of 'network modulation,' said Ken Mariash, CEO of Sinaptica Therapeutics. 'This publication presents a higher order systems-level approach to how we think about and treat brain diseases. Sinaptica's nDMN therapy induces a cascade of network-wide effects that compound, ultimately restoring the exquisite balance of the networks involved in memory and cognition. In this new context, we can better understand how it was possible to achieve such strong and consistent clinical outcomes in previous Phase 2 trials in mild/moderate Alzheimer's patients. This important publication reinforces everything we're building at Sinaptica by elucidating the neurobiological mechanisms underlying our therapy and validating the importance of targeting the brain's network-level dysfunction with both precision and personalization.'
About the SinaptiStim ® System
The SinaptiStim ® System is an investigational new approach to treating Alzheimer's disease using non-invasive personalized precision neuromodulation. Calibrated to each individual's brain, the therapy is delivered in weekly 20-minute sessions in a recliner. The SinaptiStim system delivers safe, painless, customized neurostimulation technology targeting the Default Mode Network (DMN), an important brain network associated with episodic memory, introspection, and other cognitive functions. The technology was granted Breakthrough Device Designation by the FDA in 2022.
The company is preparing for a pivotal randomized controlled clinical trial in mild-to-moderate Alzheimer's. In this trial, the treatment will be calibrated quarterly using TMS and EEG concurrently in combination with MRI-guided neuronavigation, which enables the SinaptiStim System to achieve customized precise repeatable targeting and safe-yet-effective dosage for each patient, tracking progress and adjusting over time to achieve the best possible individualized outcomes with its nDMN therapy. The pivotal trial will also be designed to determine the effects of SinaptiStim ® System on several biomarkers measuring beta amyloid, phosphorylated tau, neuroinflammation, and synaptic dysfunction.
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of novel personalized therapeutics to revolutionize the treatment of Alzheimer's and other primary neurodegenerative diseases. The company utilizes a patented non-invasive approach to treating Alzheimer's via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. Sinaptica's scientific co-founders pioneered research on this novel approach which a growing body of evidence indicates can slow disease progression. Sinaptica's mission is to bring a safe, effective, and non-invasive neuromodulation therapy to Alzheimer's patients that can help to significantly slow the progression of cognitive, functional, and behavioral decline. Learn more at sinapticatx.com and follow us on LinkedIn and X @SinapticaTX.
The SinaptiStim ® System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale in any geography.

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Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. 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Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential for ruxolitinib cream to provide a successful treatment option for pediatric patients with AD; Incyte's plans to work with FDA; and Incyte's expectations with regard to the PDUFA date for its sNDA and regulatory approval, contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and other regulatory agencies; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. 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Advertisement Last year, Gates said he visited Indiana University's School of Medicine in Indianapolis to tour the labs where teams have been researching Alzheimer's biomarkers. 5 Bill Gates (left) is speaking out about his personal experience with Alzheimer's — and his hope for progress in fighting the disease. Brian Ach 'I also got the opportunity to look under the hood of new automated machines that will soon be running diagnostics around the world,' he wrote. 'It's an exciting time in a challenging space.' One of the biggest breakthroughs in Alzheimer's research, according to Gates, is blood-based diagnostic tests, which detect the ratio of amyloid plaques in the brain. (Amyloid plaques, clumps of protein that accumulate in the brain, are one of the hallmarks of Alzheimer's.) Advertisement 'I'm optimistic that these tests will be a game-changer,' Gates wrote. 5 The elder Gates passed away in 2020 at the age of 94 after battling Alzheimer's. Bloomberg via Getty Images Last month, the U.S. Food and Drug Administration (FDA) approved the first blood-based test for patients 55 years and older, as Fox News Digital reported at the time. Traditionally, Gates noted, the primary path to Alzheimer's diagnosis was either a PET scan (medical imaging) or spinal tap (lumbar puncture), which were usually only performed when symptoms emerged. Advertisement The hope is that blood-based tests could do a better job of catching the disease early, decline begins. 5 Last month, the U.S. Food and Drug Administration approved the first blood-based test for patients 55 years and older, as Fox News Digital reported at the time. – 'We now know that the disease begins 15 to 20 years before you start to see any signs,' Gates wrote. 'A simple, accurate and easy-to-run blood test might one day make routine screening possible, identifying patients long before they experience cognitive decline,' he stated. Gates said he is often asked, 'What is the point of getting diagnosed if I can't do anything about it?' Start and end your day informed with our newsletters Morning Report and Evening Update: Your source for today's top stories Thanks for signing up! Enter your email address Please provide a valid email address. By clicking above you agree to the Terms of Use and Privacy Policy. Never miss a story. Check out more newsletters To that end, he expressed his optimism for the future of Alzheimer's treatments, noting that two drugs — Lecanemab (Leqembi) and Donanemab (Kisunla) — have gained FDA approval. 'Both have proven to modestly slow down the progression of the disease, but what I'm really excited about is their potential when paired with an early diagnostic,' Gates noted. Advertisement He said he is also hopeful that the blood tests will help speed up the process of enrolling patients in clinical trials for new Alzheimer's drugs. 5 The hope is that blood-based tests could do a better job of catching the disease early, decline begins. Monkey Business – To accomplish this, Gates is calling for increased funding for research, which often comes from federal grants. 'This is the moment to spend more money on research, not less,' he wrote, also stating that 'the quest to stop Alzheimer's has never had more momentum.' Advertisement 'There is still a huge amount of work to be done — like deepening our understanding of the disease's pathology and developing even better diagnostics,' Gates went on. 5 Microsoft Chairman Bill Gates, his wife Melinda, far left, his father Bill Gates Sr., and his step-mother Mimi Gates pose for a photo in 2007. 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