Sinaptica Therapeutics' neuromodulation device, SinaptiStim, has demonstrated promising results in a Phase II clinical trial for Alzheimer's disease. The trial met its primary and key secondary endpoints, indicating a significant slowing of disease progression over a 12-month period.
The SinaptiStim system employs tailored brain stimulation to target specific brain areas in weekly, 20-minute sessions. The focus is on the praecuneus, a key component of the brain's default mode network (DMN) involved in memory and introspection. By stimulating this area, the therapy aims to enhance brain adaptability and strengthen memory pathways, thereby preserving and reinforcing neural connections.
The data, presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference, revealed that the SinaptiStim system significantly slowed Alzheimer's progression over the 12-month Phase II study (NCT05454540) involving 32 patients. Based on these positive findings, Sinaptica Therapeutics plans to move forward with initiating a Phase III study next year.
Clinical Trial Results
Using the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) as the primary outcome measure, patients in the neuromodulation group exhibited an average CDR-SB change of 1.36 points, compared to 2.45 points in the placebo group. This represents a 44% reduction in disease progression over the one-year study duration. Secondary outcome measures further supported these findings, with treated patients showing stability in daily activities, as measured by the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL), and improvements in cognitive and behavioral scores.
This study expanded upon a previous six-month trial (NCT3778151), extending the therapy duration to 12 months for 31 original participants while maintaining blinding to their treatment assignments. An additional 17 patients were randomized, although 16 were lost to follow-up, resulting in 32 patients completing the 12-month trial.
Expert Commentary
Sinaptica's scientific co-founder, Giacomo Koch, stated, "These latest results provide new additional evidence at 12 months, building on our prior positive six-month Phase II study, supporting the potential for nDMN to slow the impairment of cognitive functions, preserve activities of daily living, and reduce behavioural disturbances in Alzheimer's patients, with no significant side-effects."
Regulatory Pathway and Market Context
Sinaptica has outlined a regulatory strategy for SinaptiStim, which received breakthrough device designation from the US Food and Drug Administration (FDA) in October 2022. Neuromodulation is emerging as a potential alternative treatment approach for conditions such as Alzheimer's disease, Parkinson's disease, migraine, and depression. Howard Fillit, chief scientific officer of the Alzheimer's Drug Discovery Foundation, suggested that future novel therapeutics might incorporate "a component of combination therapy and precision therapy strategy, aimed at slowing the progression or stopping the onset of Alzheimer's altogether."
GlobalData estimates the global neuromodulation device market will reach $11.4 billion by 2033, up from $6 billion in 2022.
