Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers
Condition(s) studied
Investigational drug(s) / intervention(s)
Acupuncture: 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.
Sham Acupuncture: 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: Donepezil 5 mg will be given once daily before bed-time for 12 weeks.
Study 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
Primary outcome measure(s)
- Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) — Change from baseline to Week 12
The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Longhua Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | China | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06417086 on ClinicalTrials.gov ↗ ← All trials in China