Abstract
BACKGROUND AND OBJECTIVE: Mild cognitive impairment (MCI) is a cognitive dysfunction syndrome defined mostly by memory or other cognitive impairments, and may serve as a precursor to Alzheimer's disease (AD). In recent years, acupuncture has gained recognition as a potential intervention for MCI, attracting significant attention as a promising and well-established therapy. In this study, we critically evaluate the clinical efficacy and safety of an innovative acupuncture approach, termed "Kidney Nourishment and Spirit Regulation", as a therapeutic modality for MCI in geriatric populations. METHODS: A prospective, randomized, single-blind, placebo-controlled, single-center clinical trial design where patients will be allocated in acupuncture, placebo (sham acupuncture sessions), or blank for eight weeks. The blank group will receive health education over the same eight-week period and will be offered compensatory acupuncture therapy after this period. The selected acupoints for this investigation include GV20, EX-HN1, GV24, GV29, CV6, CV4, PC6, KI3, LI4, LR3, HT7 and SP6. The primary outcome measure will be the Montreal Cognitive Assessment (MoCA), while secondary outcomes include the Mini Mental State Examination (MMSE), Activity of Daily Living (ADL), and Electroencephalogram (EEG). DISCUSSION: This study seeks to provide an optimum regimen for acupuncture therapy in elderly MCI patients and to provide considerable theoretical evidence for its popularization and future broad adoption. We thus postulate that the current trial data might enlighten and potentially guide future research in terms of study design refinement.