JMIR Publications

ABSTRACT

Alzheimer’s disease has no known cure. As existing pharmacologic interventions only modestly slow cognitive decline, there is a need for new treatments. Recent trials of repetitive transcranial stimulation (rTMS¬¬¬) have reported encouraging results for improving or stabilizing cognition in patients diagnosed with Alzheimer’s dementia. However, due to small samples and lack of a well-controlled double-blind design, the results to date are inconclusive. This proposal is the first large placebo-controlled double-blind study designed with sufficient statistical rigor to measure the efficacy of rTMS treatment in Alzheimer’s dementia. The proposed clinical trial investigates the short- and long-term (up to 6 months) benefit of active rTMS treatment at two doses (either 10 sessions over 2 weeks or 20 sessions over 4 weeks) compared to sham rTMS. The primary outcome measure is the change in Alzheimer Disease Assessment Scale, Cognitive subsection (ADAS-Cog) score from pre- to post- treatment. Secondary outcomes are the changes in performance on tests of frontal lobe functioning (Stroop test, verbal fluency), in neuropsychiatric symptoms (Neuropsychiatric Inventory Questionnaire) and in activities of daily living (Alzheimer’s Disease Co-operative Study - Activities of Daily Living Inventory). Tolerability of the intervention will be assessed using a modification of the Treatment Satisfaction Questionnaire for Medication (TSQM). We assess participants at baseline, after three and five weeks of intervention, and at 8, 16 and 24 weeks post-intervention. We predict that rTMS will significantly improve cognitive function, with effects lasting up to 3 months.