Cambridge, MA – October 31, 2024 – 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 the company will present an oral presentation with results of a 52-week Phase 2 study in Mild-to-Moderate Alzheimer’s disease at the Clinical Trials on Alzheimer’s Disease (CTAD) conference being held October 29-November 1, 2024, in Madrid.
Details of the oral presentation are as follows:
Title: Results of a 52-Week Phase II Trial of Repetitive TMS of the Default Mode Network in Mild to Moderate Alzheimer’s Disease
Session Name: ORAL COMMUNICATIONS: Emerging Solutions: Novel Approaches to Treating Alzheimer’s Disease
Session Date and Time: Thursday, October 31 from 11:25 a.m. to 12:00 p.m. CET
Location: Auditorium, Madrid Marriott Auditorium Hotel and Conference Center
Additional data will also be presented in a late-breaker poster by Pentara and colleagues titled “Additional Analysis of a 52-Week Phase II Trial of Neuromodulation of the Default Mode Network to Optimize Design of a Phase 3 Trial to Demonstrate Clinical Meaningfulness.”
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 weekly in 20-minute sessions in a recliner, with safe, painless, customized neurostimulation technology targeting prescribed areas of the precuneus section of the brain. The precuneus is the central hub of the Default Mode Network (DMN), an important brain network associated with episodic memory and introspection. There has been a tremendous amount of recent research identifying the DMN as playing a central role in AD pathology and progression. It is thought that stimulating the DMN increases neuroplasticity and stabilizes the brain’s electrical network, helping to preserve existing connectivity and build new memory pathways and connections.
The technology was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in 2025. In the upcoming 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 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, neural inflammation, and synaptic transmission.
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of personalized therapeutics to revolutionize the treatment of Alzheimer’s and neurodegenerative diseases. The company utilizes a novel, noninvasive approach to treating Alzheimer’s via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. This novel approach slowed disease progression by >80% on all four gold-standard cognitive and functional clinical endpoints in a placebo-controlled Phase 2 clinical study, with results published in the peer-reviewed Oxford University Press journal, Brain. The technology was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in early 2025. Sinaptica’s mission is to bring a safe, effective, and noninvasive neuromodulation therapy to Alzheimer’s patients that can help to significantly slow the progression of both cognitive and functional decline. Learn more at sinapticatx.com and follow us on LinkedIn and Twitter @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.
Media contact:
Kathryn Morris, BrightPoint
[email protected]
914-204-6412