JMIR Publications

ABSTRACT

Background:

Amnestic mild cognitive impairment (aMCI), the predominant subtype of mild cognitive impairment (MCI), carries the highest risk of progression to Alzheimer's disease (AD) among all MCI subtypes. Currently, clinical practice lacks an established, authoritative treatment method for this condition. Prior clinical evidence indicates acupuncture may enhance cognitive function in individuals with mild cognitive impairment. Further clinical evidence suggests Gold Needle therapy demonstrates significant therapeutic effects for challenging and refractory conditions; however, a critical gap exists: no clinical trials currently ascertain whether Gold Needle surpasses conventional acupuncture in treating aMCI. This trial aims to rigorously evaluate the therapeutic efficacy and safety of the Gold Needle 'Regulating Spirit' method for clinical symptoms in aMCI patients, alongside investigating its underlying imaging and biochemical mechanisms.

Objective:

The objective of this proposed study aims to identify imaging and laboratory biomarkers for early diagnosis of aMCI, thereby providing a theoretical foundation for clinical practice.

Methods:

This randomized controlled trial will recruit 90 patients diagnosed with aMCI from the Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, alongside 20 healthy volunteers. The 90 aMCI patients will be randomly allocated to one of three groups: the Gold Needle 'Regulating Spirit' group, the General Acupuncture 'Regulating Spirit' group, or a Sham Acupuncture control group. The Gold Needle "Regulate Spirit" group employs gold-based needles, the General Acupuncture "Regulate Spirit" group utilizes standard needles, and the Sham Acupuncture group administers Park needles. Participants will undergo three sessions per week of their assigned acupuncture or placebo treatment over a continuous 12-week period.

Results:

This study was initiated on September 1, 2023. As of October 30, 2025, 110 eligible participants had been enrolled, and data collection had been completed in full. Data analysis is currently underway, and the preliminary results are expected to be available by June 2025. We hypothesize that, compared with the filiform needle-based mind-regulating acupuncture group, the golden needle-based mind-regulating acupuncture group will demonstrate superior efficacy in improving cognitive impairment. This superiority will be reflected in multiple key outcome measures, including MoCA and MMSE scores, plasma biomarkers, and functional magnetic resonance imaging findings.

Conclusions:

We anticipate that by the end of the trial, we will be able to definitively ascertain whether the gold acupuncture needle technique for 'regulating spirit' offers a significant advantage in treating aMCI, and further investigate the nature of this therapeutic benefit. To offer a more efficacious intervention for the clinical management of aMCI and the prevention of Alzheimer's disease. Clinical Trial: This trial is registered with Chinese Clinical Trial Registry Controlled Trial Number ChiCTR2300074888. Registration date: August 18,2023.