A Phase II clinical trial evaluating Sinaptica Therapeutics’ neuromodulation device in Alzheimer’s disease has hit its primary and key secondary endpoints.
The SinaptiStim system uses tailored brain stimulation to target specific areas in a weekly, 20-minute painless session. The focus is on the “praecuneus,” a key part of the brain’s default mode network (DMN), which plays a role in memory and introspection. By stimulating this area, the therapy aims to boost the brain’s adaptability and reinforce memory pathways, helping preserve and strengthen connections.
Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference from 29 October to 1 November in Madrid, Spain, highlighted that the system significantly slowed Alzheimer’s progression over the 12-month Phase II study (NCT05454540) in 32 patients.
On the back of the positive data, the company said it will move forward with plans to initiate a Phase III study slated to begin next year.
Using the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) as a primary measure, patients in the neuromodulation group experienced an average CDR-SB change of 1.36 points compared to 2.45 in the placebo group – a 44% reduction in disease progression over one year. Secondary measures showed further improvements, with treated patients demonstrating stability in daily activities (measured by ADCS-ADL) and improved cognitive and behavioural scores.
This study built on a previous six-month trial (NCT3778151), extending therapy to 12 months for 31 initial participants while keeping them blinded to their treatment arms. An additional 17 patients were randomised, while 16 were lost to follow-up. In total, 32 patients completed the 12-month trial.
Sinaptica’s scientific co-founder Giacomo Koch said: “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.”
US-headquartered Sinaptica has outlined a regulatory plan for SinaptiStim. The device won breakthrough device designation from the US Food and Drug Administration (FDA) in October 2022.
Neuromodulation has emerged as an alternative treatment option for patients with diseases like Alzheimer’s, Parkinson’s, migraine, and depression. Future novel therapeutics may involve a "component of combination therapy and precision therapy strategy, aimed at slowing the progression or stopping the onset of Alzheimer’s altogether," said Howard Fillit, chief scientific officer of the Alzheimer’s Drug Discovery Foundation.
A market model by GlobalData estimates the global neuromodulation device market will be worth $11.4bn by 2033, up from $6bn in 2022.
