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

Phase

N/A

Condition

Mental Disability

Dementia

Learning Disorders

Treatment

Donepezil

Acupuncture

Clinical Study ID

NCT03810794

18401970500

Ages 50-85
All Genders
Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

aged between 50-85 years
the diagnostic criteria of Neurological Communicative Disorders and Stroke and theAlzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
cognitive impairment based on the scores of the Chinese version of the Mini MentalState Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or themedial temporal lobe volume, MRI manifestation of high possibility of AlzheimerDisease
the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
voluntarily joining this study with informed consents

Exclusion

Exclusion Criteria:

cognitive impairment caused by other factors (e.g. vascular dementia, dementia withLewy bodies, frontotemporal dementia, hormone or metabolic abnormalities,hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental andemotional disorders (such as schizophrenia and depression))
a serious heart condition, hepatic disease, renal system disease, hematopoieticsystem disease, or whole-body malnutrition
aphasia, disturbance of consciousness, or failure to cooperate with the relatedexaminations due to physical disability
anticoagulant treatments such as warfarin or heparin
use of pacemakers or receiving acupuncture in the past 2 weeks

Study Design

Donepezil

March 01, 2019

December 30, 2026

Study Description

Objective: 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.

Methods/design: A total of 180 participants with mild to moderate Alzheimer's disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil. 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 3 sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total. 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. Participants in the control group will take donepezil only. A follow-up will be conducted 24 weeks after the treatment. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12. The secondary outcomes contains The change from baseline in MMSE score, ADCS-ADL score, QOL-AD score measured at weeks 12, 24 and 36.

Connect with a study center

Huashan Hospital Fudan University
Shanghai, Shanghai 200040
China
Active - Recruiting
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai 200032
China
Active - Recruiting
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, Shanghai 200032
China
Site Not Available
Huashan Hospital Fudan University
Shanghai 1796236, Shanghai Municipality 1796231 200040
China
Active - Recruiting
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai 1796236, Shanghai Municipality 1796231 200032
China
Active - Recruiting
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai 1796236, Shanghai Municipality 1796231 200032
China
Active - Recruiting

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