Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
Healthy Volunteers
NCT06417086

Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers

Led by ZhanYJ · Updated on 2025-05-21

176

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

Z

ZhanYJ

Lead Sponsor

S

Shanghai Minimally Invasive Surgery Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture. Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes. Participants will: Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up. Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.

CONDITIONS

Official Title

Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 50-85 years
  • Diagnosed with Alzheimer's disease by NINCDS-ADRDA criteria
  • Mild to moderate cognitive impairment based on Chinese MMSE scores (11 to 22 for primary school degree, 11 to 26 for junior high school degree or above)
  • MRI confirming hippocampus or medial temporal lobe atrophy with high possibility of Alzheimer's disease
  • MTA-scale score ≥2 if under 75 years, or ≥3 if over 75 years
  • Voluntarily agree to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Cognitive impairment caused by other conditions such as vascular dementia, Lewy body dementia, frontotemporal dementia, hormone or metabolic issues, hypothyroidism, folic acid or vitamin B12 deficiency, delirium, schizophrenia, or depression
  • Serious heart, liver, kidney, blood diseases, or severe malnutrition
  • Aphasia, unconsciousness, or inability to cooperate due to physical disability
  • Contraindications for MRI such as claustrophobia or pacemaker implantation
  • Use of anticoagulant treatments like warfarin or heparin
  • Pacemaker use or acupuncture treatment within the past 2 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, China, 200032

Actively Recruiting

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Research Team

Y

Yijun Zhan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers | DecenTrialz