Abstract
BackgroundPatients with Alzheimer’s disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer’s disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer’s disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer’s disease in subjects aged over 65 years.MethodThis is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention.DiscussionThis study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer’s disease, and may be useful to enhance their quality of life.Trial registrationClinicalTrials.gov, NCT02351388. Registered on 27 January 2015. Last updated on 30 May 2016.
Highlights
Patients with Alzheimer’s disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits
This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer’s disease, and may be useful to enhance their quality of life
Neither antidepressant drugs nor Electroconvulsive therapy (ECT) have been established as a persuasive treatment for it because the former has not shown significant effect [13, 14] and the latter has not ensured its safety [17,18,19,20]
Summary
Depression is one of the most frequent NPS in patients with AD, and has a negative impact on their QOL [10]. The RCT described in this paper concerns the safety and effect of neuromodulation by weak direct current that may have a significant impact on both depression and cognition, and may be useful for patients with depression in AD to enhance their QOL. The study coordinator will remind and reschedule all of the patients’ visits as needed Another limitation in this trial would be the small sample. Further RCTs with larger samples and additional evaluations will be needed We believe that this trial is a well-designed RCT that will investigate tDCS intervention in a way which has not yet been evaluated. The principal investigator, the research coordinator, or the research assistant will be responsible for conducting the informed consent process with all the study participants.
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