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

Cognitive Impairment Alzheimer 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.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria6

aged between 50-85 years
the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
cognitive impairment based on the scores of the Chinese version of the Mini Mental State 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 the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
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 Criteria5

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

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.