Trials
Search / Trial NCT06417086

Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers

Launched by SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · May 12, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured a...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged between 50-85 years
  • Diagnosed by the 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 Criteria:
  • 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
  • Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation.
  • Anticoagulant treatments such as warfarin or heparin
  • Use of pacemakers or receiving acupuncture in the past 2 weeks

Trial Officials

Yijun Zhan

Study Chair

Shanghai University of Traditional Chinese Medicine

Houguang Zhou

Study Director

Huashan Hospital

About Shanghai University Of Traditional Chinese Medicine

Shanghai University of Traditional Chinese Medicine is a leading institution dedicated to advancing the field of traditional Chinese medicine through rigorous research and innovative clinical practices. With a strong emphasis on integrating traditional methodologies with modern scientific approaches, the university aims to enhance healthcare outcomes and promote holistic wellness. As a sponsor of clinical trials, it is committed to exploring the efficacy and safety of traditional therapies, contributing to evidence-based practices, and fostering collaborations that bridge Eastern and Western medical paradigms. The university's focus on education, research, and community engagement positions it as a pivotal player in the global health landscape.

Locations

Shanghai, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0