RecruitingNot ApplicableNCT06417086

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


Sponsor

ZhanYJ

Enrollment

176 participants

Start Date

Jun 1, 2024

Study Type

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether acupuncture can improve thinking and memory in people with Alzheimer's disease. It is also investigating whether having a particular genetic variant (APOE e4) — the strongest known genetic risk factor for Alzheimer's — affects how well someone responds to acupuncture treatment. **You may be eligible if...** - You are between 50 and 85 years old - You have been diagnosed with mild to moderate Alzheimer's disease - Your cognitive test scores fall within the range for mild to moderate Alzheimer's (based on education level) - Brain imaging (MRI) shows shrinkage in the hippocampus or medial temporal lobe consistent with Alzheimer's disease - You are willing to join voluntarily and sign consent **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's (e.g., vascular dementia, thyroid problems, B12 deficiency) - You have a serious heart, liver, kidney, or blood condition - You have aphasia (difficulty speaking) or severe physical disability affecting cooperation - You have a contraindication to MRI (e.g., claustrophobia, pacemaker) - You are taking blood thinners like warfarin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAcupuncture

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.

OTHERSham 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.

DRUGDonepezil

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06417086


Related Trials