Positive Interim Results in Alzheimer's Trial
27 September, 2011
Brainsway Ltd. is pleased to announce that it has received additional interim results of a clinical trial being conducted at the Ichilov Medical Center in Israel to explore the efficacy of Deep TMS in the treatment of Alzheimer's disease.
The interim results are for 24 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.
The treatment was well-tolerated by all subjects, with no side-effects, except for one incident involving a sham control subject, 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 a 4.2-point improvement in the high-frequency treatment group, compared with a 1.8-point improvement in the sham control group, and a 1.4-point deterioration in the scores of the low-frequency treatment group, the latter occurring mainly during the 8 weeks post treatment. In addition, 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).
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. Similar to the ADAS-Cog test results, these scores also indicated a worsening in the condition of patients treated with low-frequency electromagnetic stimulation.
The principal investigator commented, "The interim results from the trial indicate that Deep TMS therapy for Alzheimer's disease patients is safe and side-effect-free. Although the small sample size somewhat hampers our ability to draw any definitive conclusions concerning treatment efficacy, the results nonetheless suggest that high-frequency treatment leads to improvement on Alzheimer's disease assessment scales, whereas low-frequency and sham treatment do not."