RecruitingNot ApplicableNCT03810794

Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease

Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial


Sponsor

Jian Pei,MD

Enrollment

180 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this proposed study is to evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale. In this 12-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as additional treatment with Donepezil, a total of 180 patients with Alzheimer's disease will be recruited. The patients will be randomly assigned to acupuncture combined with Donepezil (n =90) or Donepezil treatment (n =90). (36 sessions, 3 sessions a week). Changes in the cognition over time measured using ADAS-cog is the primary outcome. MMSE, ADCS-ADL and QOL-AD are the secondary outcomes. The study will be conducted at LongHua Hospital Shanghai University of Traditional Chinese Medicine, Huashan Hospital Fudan University, and Mental Health Center Shanghai Jiao Tong University School of Medicine.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating whether acupuncture (traditional needle therapy) can improve memory, thinking, and daily functioning in people with mild to moderate Alzheimer's disease. **You may be eligible if...** - You are between 50 and 85 years old - You have been diagnosed with mild to moderate Alzheimer's disease - Your memory test scores (Mini Mental State Examination, MMSE) fall in the mild-to-moderate range - An MRI scan has shown changes in brain areas typically affected by Alzheimer's (such as the hippocampus or medial temporal lobe) - You are willing and able to give your consent to participate **You may NOT be eligible if...** - You have severe Alzheimer's disease (very low MMSE scores) - Your brain changes on MRI are not consistent with Alzheimer's disease - Your MRI rating for brain shrinkage does not meet the required threshold - You have other conditions that could affect participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAcupuncture

The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total.

DRUGDonepezil

Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.


Locations(3)

LongHua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Shanghai Mental Center, Shanghai Jiaotong University of Medicial School

Shanghai, Shanghai Municipality, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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NCT03810794


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