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RECRUITING
NCT06417086
NA

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

Sponsor: ZhanYJ

View on ClinicalTrials.gov

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.

Official title: Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2024-06-01

Completion Date

2026-11-30

Last Updated

2025-05-21

Healthy Volunteers

Yes

Interventions

OTHER

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.

OTHER

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.

DRUG

Donepezil

Donepezil 5 mg will be given once daily before bed-time for 12 weeks.

Locations (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, China