Interim Results of a Clinical Trial in Alzheimer’s Disease Patients
24 January, 2010
Brainsway is pleased to announce interim in respect of the first 10 patients treated in a clinical trial of the Company’s Deep TMS device for the treatment of Alzheimer’s disease currently being performed at the Ichilov Medical Center. The results were reported to the Ministry of Health’s Medical Devices Department in a safety and efficacy report submitted by the trial’s principal investigator, Dr. Eliyahu Simon.
The treatment was well-tolerated by all ten patients, with no side effects. The hospital’s Helsinki committee was notified of several incidents, which the principal investigator believes were unrelated to the treatment.
The trial used the Mini Mental State Examination (MMSE) and the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) test to assess the efficacy of treatment. These are the main assessment scales used to evaluate efficacy in the literature. The following efficacy test results are based on six patients who completed all stages of the study performed thus far, out of the ten patients treated. One of the patients in the control group was removed from the study at the discretion of the principal investigator.
The MMSE results of the six patients who have completed all stages of the study thus far indicate a modest improvement in the scores of the active treatment group as compared with the sham control group.
The ADAS-Cog results of the six patients who have completed all stages of the study thus far indicate a significant improvement in the scores of the active treatment group as compared with the sham control group.
According to the principal investigator’s interim report, these results indicate significantly improved cognitive function among patients who underwent Deep TMS treatment.
Dr. Simon concludes the report by saying that ”In light of the aforementioned, in terms of both safety and efficacy, I am asking the Ministry of Health to authorize continuation of the trial of Deep TMS as an add-on treatment to drug therapy in Alzheimer’s disease patients. It is imperative to find a way to ease the suffering of Alzheimer’s disease patients, as the current treatments for this disease are highly limited”.