drugset / Trial / NCT03810794

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

NCT03810794

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-03-01
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Background Donepezil Small molecule 5 mg