Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers
Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial
ZhanYJ
176 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
Interventions
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. There will be 12 weeks of 3-session treatment for each participant in total.
The Streitberger placebo needle will be used to simulate an acupuncture procedure without penetrating the skin. 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. There will be 12 weeks of 3-session treatment for each participant in total.
Donepezil 5 mg will be given once daily before bed-time for 12 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06417086