Neuromodulation Slows Alzheimer’s Brain Atrophy

Sinaptica's neuromodulation therapy slows Alzheimer's brain atrophy

Researchers at Sinaptica Therapeutics have found that their new personalized therapy, using rTMS-EEG, which shows promising potential in slowing brain atrophy and enhancing brain connectivity in Alzheimer’s patients.

This innovative non-invasive treatment targets the Default Mode Network (DMN), a critical brain area for memory severely affected by Alzheimer’s disease.

The significance of this research cannot be overstated.

Alzheimer’s is a growing crisis, with approximately 5.8 million Americans affected in 2020, a number projected to nearly triple to 14 million by 2060 (source: CDC).

Sinaptica Therapeutics, Inc., a clinical-stage company based in Cambridge, Massachusetts, specializes in developing personalized neuromodulation therapeutics for Alzheimer’s and other neurodegenerative diseases.

But how does this therapy work exactly?

The study, titled “Macro and micro structural preservation of grey matter integrity after 24 weeks of rTMS in Alzheimer’s disease patients: a pilot study,” stems from a larger randomized Phase 2 trial. It unveils compelling findings that could redefine treatment approaches for Alzheimer’s. Using advanced MRI and fMRI neuroimaging analyses, researchers observed profound effects of Sinaptica’s therapy on structural and connectivity changes in patients with mild-to-moderate Alzheimer’s.

Macro and micro structural preservation of grey matter integrity after 24 weeks of rTMS in Alzheimer’s disease patients: a pilot study

Key insights from the study underscore the therapy’s efficacy in slowing the progression of Alzheimer’s pathology.

Moreover, MRI scans revealed a notable slowdown in grey matter atrophy within the Precuneus, a pivotal node within the DMN crucial for episodic memory and early targeted by amyloid deposits in Alzheimer’s.

And what about functional MRI?

Functional MRI demonstrated enhanced connectivity not only in the Precuneus but also across the broader DMN.

The study involved a subset of 16 patients from the larger Phase 2 trial, each undergoing rigorous evaluation through structural and functional MRI measurements at baseline and post-treatment.

The therapy regimen comprised two phases:

  • Intensive Phase: 10 daily sessions over the first two weeks.
  • Maintenance Phase: 22 weekly sessions over the subsequent 22 weeks.

Experimental paradigm. Overview of the protocol design characterized by two phases, a daily “intensive” phase, and a weekly “maintenance” phase. At the beginning and the end of the treatment (week 0 and week 24), we collected structural and functional MRI

Experimental paradigm. Overview of the protocol design characterized by two phases, a daily “intensive” phase, and a weekly “maintenance” phase. At the beginning and the end of the treatment (week 0 and week 24), we collected structural and functional MRI

These findings suggest that Sinaptica’s approach not only preserves brain structure but also fosters the integration of key neural networks critical for memory and cognitive function.

Functional connectivity results.

Functional connectivity results. Increase (A) and decrease (B) of functional connectivity in the PC-rTMS as compared to the Sham group after 24 weeks of stimulation are shown. The analysis was performed using the PC as seed. (C) & (D) represent the network mapping results showing the belonging of the positive cluster (the precuneus cortex) to the DMN (in the red squares) and of the negative cluster (the left superior parietal lobule) to the DAN (in the blue squares). Images are shown in neurological convention. (E) The significant correlation between FC (both positive and negative clusters) and GM changes (pre-post) after 24 weeks of PC-rTMS is shown. No correlation was found among the changes of FC over the SPL and GM changes

These findings suggest that Sinaptica’s approach not only preserves brain structure but also fosters the integration of key neural networks critical for memory and cognitive function.

Dr. Giacomo Koch, Sinaptica’s scientific co-founder and lead researcher, highlighted the study’s significance. “Our research represents a significant milestone in Alzheimer’s treatment. We’ve shown that targeted neuromodulation can not only preserve brain structure but also facilitate the development of new neural connections crucial for memory and cognition.”

Ken Mariash, CEO of Sinaptica, emphasized the broader implications of these findings: “Our Phase 2 clinical data not only validate the efficacy of our non-invasive therapy in slowing disease progression but also underscore its potential to induce neuroplasticity and mitigate the disconnectivity observed in Alzheimer’s. These results are pivotal as we progress towards larger clinical trials and strive to make this transformative therapy accessible globally.”

Sinaptica is advancing based on robust data from their full nDMN Phase 2 study in Alzheimer’s, revealing significant reductions in disease progression as evidenced by primary and secondary endpoints.

Specifically, the Clinical Dementia Rating – Sum of Boxes (CDR-SB) and Alzheimer’s Activities of Daily Living (ADCS-ADL) both showed over 80% disease slowing, alongside other cognitive measures (ADAS-COG and MMSE) at six months, as detailed in the journal Brain by the company’s scientific co-founders.

Importantly, the treatment proved well tolerated, with no serious adverse events observed during the six-month treatment period.

Moreover, Sinaptica has completed a second Phase 2 study with a 1-year endpoint, slated for imminent publication in a peer-reviewed journal and presentation at CTAD in October.

With FDA Breakthrough Device Designation for their patented technology, Sinaptica is now gearing up for Phase 3 trials in Alzheimer’s patients across multiple sites.

These pivotal studies aim to further validate the therapy’s safety and efficacy across a broader patient population, marking a significant step toward obtaining regulatory approval for clinical use.

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/20240709586783/en/

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