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

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.

Conditions

• Alzheimer Disease
• Cognitive Impairment

Interventions

OTHER

Acupuncture

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.

DRUG

Donepezil

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.

Sponsors & Collaborators

• Shanghai Mental Health Center

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Jian Pei,MD

  lead OTHER

Principal Investigators

• Jian Pei, Doctor · Shanghai University of Traditional Chinese Medicine

• Houguang Zhou, Doctor · Huashan Hospital

• Tao Wang, Doctor · Mental Health Center Shanghai Jiao Tong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• China

Study Locations