Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial

Neurodegener Dis Manag. 2021 Aug;11(4):277-288. doi: 10.2217/nmt-2020-0061. Epub 2021 Jul 9.

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 NCT04404153 (Clinicaltrials.gov).

Keywords: Alzheimer’s disease; at-home tDCS; clinical trial protocol; dementia; noninvasive neurostimulation; transcranial direct current stimulation (tDCS).

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Alzheimer Disease / therapy*
  • Cognition*
  • Double-Blind Method
  • Executive Function
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neuronal Plasticity
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Transcranial Direct Current Stimulation / methods*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT04404153