Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers
Recruiting · NCT06417086 · Interventional (participants receive a specific treatment) · Lead sponsor: ZhanYJ
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture. Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes. Participants will: Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up. Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.
Who can take part
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
Where it is running
1 location listed.
- Longhua Hospital, Shanghai University of Traditional Chinese Medicine - Shanghai, China