Jerusalem, Israel November 8, 2012 -- Brainsway® Ltd. (TASE:BRIN) is pleased to announce the final results of a double-blind, placebo-controlled clinical study that was conducted at the Ichilov Medical Center in Israel to explore the efficacy of Deep TMS in the treatment of Alzheimer's disease.
The trial recruited a total of 40 patients that were divided into three groups: a sham stimulation control group, a low-frequency (1 Hz) treatment group and a high-frequency (10 Hz) treatment group. Each subject received treatment over 8 weeks, and the efficacy of the treatment was evaluated both during the trial and over the course of the subsequent 8-week period. Of the 40 patients enrolled, the final results are for 38 subjects that completed the entire study. The two subjects that were enrolled in the study, but for which complete data sets were not obtained, were part of the low frequency treatment group.
The treatment was well tolerated by all subjects, with no side effects, except for two incidents which the principal investigator believes to be unrelated to the treatment.
The trial used the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) test (the main efficacy scale used in Alzheimer's disease clinical trials), as well as additional accepted scales of disease severity (CGI, ADL, CDR) and a quality-of-life scale (QoL Caregiver Scale) to assess the efficacy of treatment. These are the main assessment scales used to evaluate efficacy in the literature.
Analysis of ADAS-Cog results revealed an average 3.1-point improvement (0.9 points after eight weeks and a further improvement of 2.2 points after 16 weeks) in the high-frequency treatment group, compared with a 1.4-point average deterioration (unchanged after eight weeks and a worsening of 1.1 points after 12 weeks) in the scores of the sham control group. The total difference between the high-frequency treatment group and the sham control group was an average of 4.2 points. Moreover, 18% of the high-frequency treatment group showed an improvement of at least 8 points compared with 7% of the placebo group. In the high-frequency treatment group, severity of cognitive impairment at entry into the trial was correlated with clinical improvement (the more severe the cognitive impairment, the more the patient improved following treatment). There was a significant difference in the improvement in the Composite Cognitive Score, which was tested by using the “Minstrim” computerized index, between the group receiving high-frequency treatment and the sham control group (P <0.05). CDR, ADL, CGI and QoL Caregiver Scale scores indicated that high-frequency treatment halted the deterioration of the disease and even produced a moderate improvement relative to sham treatment.
The principle investigator concluded that the study results suggest that Deep TMS treatment for Alzheimer’s patients is safe and without side effects. In addition, despite the inability to draw conclusive observations with respect to efficacy due to its small size, the study results indicate that high-frequency Deep TMS therapy improves conventional measures in relation to the sham control group. In light of these results, the principal investigator recommends that a larger multicenter trial be conducted.
Uzi Sofer, Brainsway’s CEO, said, ”We are now making preparations for a larger multicenter trial as recommended by the principal investigator. As our therapeutic pipeline continues to expand, so too does our market opportunity. More importantly, we believe that Deep TMS offers real hope to the large patient population suffering from chronic, and often incurable, brain conditions like Alzheimer’s disease.”