Positive Data Published in Alzheimer's Research & Therapy from 12-month Phase 2 Study in Alzheimer's Using Personalized Neuromodulation Therapy; Trial Met All Primary and Key Secondary Endpoints
Personalized Neuromodulation (nDMN) targeting the Default Mode Network slowed Alzheimer's in all 3 clinically measured domains: cognition, function, and behavior—with no serious side-effects
This positive peer reviewed 52-week study builds upon prior positive clinical studies and provides important additional evidence on long-term safety and treatment durability.
CAMBRIDGE, Mass., April 02, 2025--(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 positive results of a 52-week Phase 2 study in Mild-to-Moderate Alzheimer's disease patients conducted by the company's scientific co-founder Dr. Giacomo Koch were published in the peer-reviewed journal Alzheimer's Research & Therapy. The publication is titled, "Effects of 52 weeks of Precuneus rTMS in Alzheimer's Disease Patients: a Randomized Trial."
The data, also presented in a podium session at the Clinical Trials on Alzheimer's Disease (CTAD) conference in October 2024 in Madrid, showed that non-invasive personalized neuromodulation of the Default Mode Network (DMN), a key network in the brain involved in memory and cognition, using rTMS-EEG, met all key endpoints with statistical significance, with no serious side-effects.
"This publication reaffirms our confidence in the potential for our non-invasive precision neuromodulation therapy, nDMN, to slow the impairment of cognitive functions, preserve activities of daily living, and reduce behavioral disturbances in Alzheimer's patients," 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. "We continue to build on our positive clinical evidence including with a just-initiated Phase 2 study in Early Alzheimer's patients, as well as ongoing preparations to launch a pivotal trial in Mild-to-Moderate patients."
Additional analysis from the study included in the publication showed that propagation of the neuromodulation pulses from the precuneus (the stimulation location) to the medial prefrontal cortex was correlated with the primary outcome measure, CDR-SB, implying that the propagation of the signal throughout known areas of the DMN, confirmed via TMS-EEG, is an important requirement for efficacy.
This now published Phase 2 study was a monocentric, randomized, double-blind, sham-controlled, 52-week trial to determine the safety and efficacy of treatment with personalized neuronavigated repetitive transcranial magnetic stimulation (rTMS) targeting the Default Mode Network, the primary functional brain network impacted by Alzheimer's disease. Additional details on the study design are available in a Sinaptica press release at CTAD.
"These peer reviewed results not only highlight the treatment's durability in all disease domains over one year, but the data also points to the importance of confirming broad network engagement of the DMN by measuring distal evoked potentials via neuronavigated TMS-EEG technology," said Ken Mariash, Sinaptica CEO. "This highly personalized approach ensures the neuromodulation pulses can reach distal targets in the DMN so as to induce widespread neuroplasticity throughout the DMN—and furthermore to personalize the dose for every patient to stay within safe-yet-effective bounds."
Summary of Results
The study showed that personalized neuromodulation of the Default Mode Network (nDMN) had a significant effect on the primary outcome measure, Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB). The estimated mean change in CDR-SB after 52 weeks was 1.36 for rTMS-EEG group (95% confidence interval (CI) [0.68, 2.04]) and 2.45 for sham group (95%CI [1.85, 3.05]), resulting in a statistically significant and clinically meaningful separation of 1.09 points, representing a 44% slowing of Alzheimer's progression over the 12-month study duration.
There were also statistically significant effects for the secondary outcomes ADAS-Cog11, MMSE, ADCS-ADL and NPI scores.
On key functional secondary outcome measure, Activities of Daily Living (ADCS-ADL), patients receiving treatment had retained nearly all activities of Daily Living after 1 year, losing only 1.5 points, whereas the placebo arm lost 11.6 points TMS-EEG showed that rTMS increased functional connectivity within the Default Mode Network, and such increase correlated with the changes in clinical scores as measured by the CDR-SB
The procedure was safe and well tolerated with very few minor adverse events reported.
About the SinaptiStim® SystemThe 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 sessions in a recliner ranging from 20 minutes with the first-generation system to six minutes with the second-generation system. 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 with its first-generation system. 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 TherapeuticsSinaptica 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250402960979/en/
Contacts
Kathryn Morris, BrightPointkathryn@brightpointny.com 914-204-6412
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
33 minutes ago
- Business Wire
Cotiviti's Quality Measurement and Reporting Solution Achieves 25th Consecutive Year of HEDIS ® Measure Certification
SALT LAKE CITY--(BUSINESS WIRE)--Quality Engine, the administrative measure logic and sample processing component of Cotiviti's Quality Intelligence solution, has earned HEDIS ® Certified Measures™ status from the National Committee for Quality Assurance (NCQA) for Measurement Year (MY) 2025. HEDIS Measure Certification validates that Cotiviti's measures have been put through the thorough testing required to effectively support health plans with the HEDIS MY 2025 season. This milestone marks an industry-leading 25 consecutive years of certification, demonstrating Cotiviti's ability to adapt and serve as a long-term partner to health plans as the HEDIS program continually evolves. This milestone marks an industry-leading 25 consecutive years of certification, demonstrating Cotiviti's ability to adapt and serve as a long-term partner to health plans as the HEDIS program continually evolves. Share 'The ongoing transition to fully digital quality measurement requires health plans to have a quality improvement solution that not only meets the highest standards for accuracy, but continually evolves to meet and exceed new requirements,' said Emad Rizk, M.D., chairman, president, and CEO of Cotiviti. 'This achievement reflects Cotiviti's unwavering commitment to supporting our health plan clients. It speaks to the deep expertise we've built through decades of working with billions of data points, navigating complex measurement requirements, and helping our clients meet the changing demands of quality reporting.' Cotiviti's Quality Intelligence processes more than 147 million member lives reported to NCQA and serves as a comprehensive measurement and reporting solution that streamlines compliance while supporting HEDIS, state-specific, and other quality measure submissions. Newly launched in 2025, Cotiviti's Engagement Hub integrates with Quality Intelligence to drive coordination and efficiency through a centralized member engagement and reporting platform, enabling plans to close care gaps to ultimately improve quality scores. Further integrations within Cotiviti's quality improvement ecosystem support year-round quality improvement and enable better member health. When integrated with Cotiviti's Star Intelligence, Quality Intelligence provides a centralized platform for managing both HEDIS and Star Ratings, helping clients ensure consistency across programs and maintain compatibility with historical data to support accurate trending and projections. Cotiviti's scalable medical record retrieval and abstraction services also connect directly with the solution to enable end-to-end support for health plans throughout the HEDIS season. 'Payers need a trusted partner in quality improvement with a longstanding track record of success to help them navigate the digital quality transition and deliver high-performing, reliable solutions that have been continuously refined and supported over decades,' said Chad Kinkead, executive vice president of risk adjustment, quality, and engagement for Cotiviti. 'Cotiviti's Quality Intelligence supports all members and lines of business with end-to-end capabilities for accurate processing, reporting, audits, and submissions, backed by a team of experts who are committed to supporting health plans during and after the transition to digital reporting. Our clients can anticipate further innovation as we integrate Cotiviti's industry-leading quality improvement, DxCG risk assessment, engagement, and risk adjustment solutions with Edifecs ' leading NLP-enabled coding platform, interoperability capabilities, and AI-enabled value based-payment solutions." About Cotiviti Cotiviti enables healthcare organizations to deliver better care at lower cost through advanced technology and data analytics that improve the quality and sustainability of healthcare in the United States. Cotiviti's solutions increase transparency and collaboration between payers and providers while empowering them to reduce medical and administrative costs, enable better health, improve claims payment efficiency, streamline operations, drive interoperability, and advance value-based care. Its customers serve the majority of U.S. healthcare consumers, providing coverage and care for over 300 million members and patients. Additionally, Cotiviti offers data management and recovery audit services to the retail sector to improve business outcomes. For more information, visit About NCQA NCQA is a private, non-profit organization dedicated to improving healthcare quality. NCQA accredits and certifies a wide range of healthcare organizations. It also recognizes clinicians and practices in key areas of performance. NCQA's website contains information to help consumers, employers and others make more informed healthcare choices.
Yahoo
an hour ago
- Yahoo
Crinetics Pharmaceuticals, Inc. (CRNX)' Oral Acromegaly Drug Nears FDA Decision After Strong Phase 3 Data
We recently compiled a list of Crinetics Pharmaceuticals, Inc. stands fifth on our list. Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) stands fifth on our list among the best future growth stocks to buy now. It is a clinical-stage biopharmaceutical company focused on developing oral, small-molecule therapies for rare endocrine diseases and tumors. Its lead candidate, PALSONIFY (paltusotine), is an investigational once-daily oral somatostatin receptor type 2 (SST2) agonist being developed for acromegaly. At the July 2025 ENDO Annual Meeting, Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) presented long-term data from the open-label extensions of its PATHFNDR-1 and PATHFNDR-2 Phase 3 trials, showing that PALSONIFY maintained durable IGF-1 control, reduced symptom burden, and had a consistent safety profile. These findings strengthen its case as a next-generation oral alternative to current injectable therapies, which are the standard of care for acromegaly. The company is now approaching a major inflection point, with a PDUFA date set for late 2025, potentially making PALSONIFY the first oral treatment approved for acromegaly. This would represent a significant shift in disease management and convenience for patients. A scientist in a laboratory looking into a microscope, researching advances in biopharmaceuticals for central nervous system disorders. Beyond PALSONIFY, Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) is advancing other pipeline programs, including Atumelnant, aimed at treating congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, as well as several early-stage endocrine disorder therapies. The corporation also expanded its workforce in July 2025, granting equity awards to 46 new employees to support future growth. While we acknowledge the potential of GOOGL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Sign in to access your portfolio
Business Wire
an hour ago
- Business Wire
Materna Medical Completes Enrollment in EASE Trial of Ellora™ Obstetrical System Used in First-Time Mothers
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Materna Medical, a women's health company dedicated to developing innovative solutions for pelvic floor disorders, today announced the successful completion of enrollment in its EASE pivotal trial (NCT03973281). The trial enrolled 420 first-time mothers to evaluate the safety and effectiveness of the investigational Ellora™ Obstetrical System for reducing pelvic muscle injury during vaginal delivery in first-time mothers. The EASE study is a prospective, randomized controlled clinical trial being conducted at 20 leading U.S. hospital clinical sites and is designed to assess the safety and effectiveness of the Ellora expanding vaginal dilator (formerly Materna Prep device) in reducing pelvic muscle injury during vaginal delivery. "The completion of enrollment in the EASE study represents an exciting opportunity to understand and potentially reduce the risk of vaginal childbirth-related pelvic floor trauma,' said Helai Hesham, MD, urogynecologist and EASE lead investigator at Columbia University Irving Medical Center, NY. 'The rigorous design of this pivotal trial, building on the promising published results of the EASE Phase 2 Study, is essential for evaluating the potential of Ellora to improve maternal health outcomes.' Vaginal childbirth-related pelvic floor injuries, specifically complete levator ani muscle (LAM) avulsion—where a group of pelvic floor muscles detaches from the pelvic bone—are linked to pelvic organ prolapse, whose symptoms can include pelvic pressure, pain, urinary and/or fecal incontinence, and sexual dysfunction. The investigational Ellora Obstetrical System includes an expanding vaginal dilator designed to prepare the vagina to better withstand the strain of childbirth, aiming to reduce the incidence and severity of these significant LAM injuries. 'Completing enrollment in our EASE pivotal trial is a monumental milestone for Materna Medical and is a significant step forward in our mission to protect women from childbirth injuries,' said Tracy MacNeal, CEO of Materna Medical. 'We are incredibly grateful to the patients and clinical investigators participating in this groundbreaking trial. Their commitment brings us closer to potentially offering a much-needed intervention to improve birth outcomes for mothers globally.' 'The focus of innovation has traditionally been on the difficult challenge of fixing women's pelvic health damage that has already occurred, rather than protecting the pelvic floor and preventing these problems from happening in the first place," said Ariella Golomb, MD, Partner and Founder, InnovaHealth Partners, and Materna Board Chair. "Materna's approach to reducing the incidence of pelvic floor injuries is a tremendous opportunity to transform the standard of care in obstetrics and provide women with a chance to enter motherhood without the anatomical setbacks from childbirth. We're thrilled to see this landmark study complete its enrollment." Results from the Phase 2 EASE trial were published in the August 2024 Issue of the International Urogynecology Journal: 'Effect of an intrapartum pelvic dilator device on levator ani muscle avulsion during primiparous vaginal delivery: A pilot randomized controlled trial.' Materna Medical is now focused on analyzing the EASE study data to support an upcoming FDA submission for the Ellora Obstetrical System. About Us Materna Medical Materna Medical is a novel OBGYN platform company defining a $25B market with core technologies addressing unmet needs in women's pelvic health. With headquarters in Mountain View, California, Materna pulls from the top minds in MedTech to truly transform the standard of care in OBGYN. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical's mission is to empower women to protect their pelvic health. Our first product, Milli™, is a vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device launched as a wellness trainer and, in 2023, received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes have been studied in a post-market prospective virtual study named POMPOM. Materna's second product, Ellora™, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery in first-time moms. This product is being studied in the EASE trial, a large, randomized controlled trial in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic floor health for moms. Reference Hesham, H., Orejuela, F., Rood, K.M. et al. Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial. Int Urogynecol J 35, 1839–1849 (2024).
