Sinaptica Therapeutics announces Phase 2 trial results for Alzheimer's Disease

According to phase 2 trial data published by Sinaptica Therapeutics, PC-rTMS, a precision-delivered noninvasive brain stimulation, delayed cognitive and functional deficits in those with mild-to-moderate dementia caused by Alzheimer's disease.

50 patients were included in a 24-week Phase II randomised, double-blind, sham-controlled trial and underwent a novel diagnostic assessment that used electroencephalography (EEG) and transcranial magnetic stimulation (TMS) to tailor critical therapy parameters to each patient.

The cognitive decline of those who received active therapy in the 50-patient, double-blind, sham-controlled trial was slowed by 82% at 6 months compared to those who received sham therapy, as indicated by a treatment difference of 1.3 points on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score (P =.009).

The findings of what is one of the largest such studies on brain stimulation in AD demonstrated that PC-rTMS is safe and well tolerated by AD patients as adverse events (AE) were few and mild.

Patients between the ages of 50 and 85 who had a CDR score of 0.5 to 1, a screening Mini-Mental State Examination score of 18 to 26, and CSF fluid biomarker evidence of AD amyloid and tau pathology were included in the study.

The trial began with a 2-week intensive course and ended with a 22-week maintenance phase, randomly assigning patients 1:1 to PC-rTMS or sham-rTMS. 40, 2-s strains administered at 20 Hz, spaced out by 28 s, made up each rTMS session. It should be noted that for each subject, the precuneus location remained constant during the entire trial.

Additionally, patients in the therapy group outperformed the sham group on three crucial secondary outcome measures, which were statistically significant.

Besides, precuneus cortical excitability in the treatment group remained stable after six months. However, it was significantly decreased in the sham group as a reflection of a pathological reduction in brain activity, indicating a neuroprotective treatment effect.

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