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Clinical Trial Protocol

Neurostimulation for Cognitive Enhancement in Alzheimer’s Disease (the NICE-AD study): A Randomized Clinical Trial

ORCID Icon, ORCID Icon, , , , , , & show all
Pages 277-288 | Received 19 Nov 2020, Accepted 23 Jun 2021, Published online: 09 Jul 2021
 

Abstract

New therapies for symptoms in Alzheimer’s disease (AD) are urgently needed. Prior studies suggest that transcranial direct current stimulation (tDCS), a noninvasive neuromodulatory method, may be a safe and potentially effective treatment, but conclusions have been limited by small-sample sizes and brief stimulation protocols. This double-blind randomized trial involving 100 older adults with mild-to-moderate AD examines effects of 6 months of at-home active tDCS or sham delivered over the dorsolateral prefrontal cortex. The primary outcome is global cognitive performance. Secondary outcomes include executive-control/spatial selective attention, functional neuroplasticity, depressive symptoms, quality of life and the durability of effects 3 months after the stimulation period. The results will provide evidence on the efficacy of multimonth at-home tDCS in the AD treatment.

=Clinical trial identifier NCT 04404153 (Clinicaltrials.gov).

Financial & competing interests disclosure

This work is supported by a grant from the National Institutes of Health (1 R01 AG068167-01). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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