Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices.

Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI).

Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients.

This study aims to assess the clinical effect of acupuncture on gait performance in AD patients and to examine the acupuncture effect on cerebral cortices by identifying hemodynamic changes that occur in the prefrontal cortices using the fNIRS technique.

The inclusion criteria are as follows:

1. Aged 40-85 years old;
2. Meeting the mentioned-above diagnostic criteria from traditional Chinese medicine and Western medicine;
3. With mild to moderate dementia (CDR=0.5, 1.0, or 2.0 points);
4. Hachinski Ischemic Scale (HIS) ≤ 4 points;
5. Hamilton Depression Rating Scale (HAMD) < 20 points;
6. Without severe bone and joint diseases and able to walk independently;
7. Able to conduct vision and hearing tests;
8. Volunteering to participate in this trial and signing an informed consent form. Exclusion criteria

The exclusion criteria are as follows:

1. Dementia caused by other systemic or neurological diseases, such as central nervous system infections, post-traumatic dementia, Parkinson's disease dementia;
2. Suffering from acute illness, upper limb extrapyramidal stiffness, neurological or psychiatric disorders (except cognitive impairment);
3. With medical history that interferes with cognitive function assessment, such as past history of psychiatric drug abuse, drug addiction within the past 5 years, and alcohol abuse;
4. Afraid of acupuncture and cannot accept acupuncture treatment;
5. Currently participating in other clinical trial that affects the outcome evaluation of this trial.