For nearly a decade, Neuronix has been conducting clinical studies that have confirmed the safety and effectiveness of its solution for treatment of mild to moderate AD. Top experts in the field were recruited to lead the studies, and findings have been presented in international conferences on AD and shared in various publications. In addition, clinical studies performed by independent investigators have also reinforced previous findings. The clinical results support the testimonials of patients who have undergone the treatment in private clinics.
In 2016 Neuronix completed a multi-center pivotal study performed in the United States which assessed the safety and efficacy of the NeuroADTM Therapy System in patients with mild to moderate Alzheimer’s disease (AD). It was a prospective, double-blind, sham controlled, multi-center study conducted in 9 centers across the U.S. and 1 center in Israel. The study involved 130 patients aged 60-90 with mild to moderate AD.
The patients underwent 30 treatment sessions – 5 sessions a week for 6 weeks. They were then evaluated prior to treatment, immediately following the treatment, and at 12 weeks follow-up. The study endpoints included both cognitive outcomes and functional/behavioral outcomes.
The cognitive outcomes were evaluated using The Alzheimer’s Disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) which primarily assesses language and memory skills. The functional and behavioral results were measured using the ADCS-CGIC Alzheimer Disease Cooperative Study – Clinical Global Impression of Change score which evaluates clinically meaningful change.
Results showed a favorable safety profile, with no patients experiencing seizures or other persistent, serious adverse events. All related adverse events were mild and transient (e.g. headache, scalp discomfort, neck pain or fatigue).
In the group of patients with baseline ADAS-Cog ≤30, which represented 85% of the enrolled population, a positive and statistically significant difference of -1.8 points in ADAS-Cog was noted between the Active Group and Sham Group at the 12 weeks follow-up.
Study results were presented in leading international Alzheimer conferences (Clinical Trials in Alzheimer’s Disease, 2016; Alzheimer’s Disease – Parkinson’s Disease, 2017), and were submitted for publication.
In the group of patients with baseline ADAS-Cog<=30, which represented 85% of the enrolled population, the Active group outperformed the Sham group on average by -0.45 points in ADCS-CGIC scale. Furthermore, only 12% of patients worsened on the ADCS-CGIC scale in the Active group versus 40% of patients in the Sham group.