Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417086
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-12
Brief Title:
Clinical Evaluation of Acupuncture Treatment on Alzheimers Disease in APOE e4 Carriers and Non-Carriers
Sponsor:
Shanghai University of Traditional Chinese Medicine
Organization:
Shanghai University of Traditional Chinese Medicine
Study Overview
Official Title:
Clinical Evaluation of Acupuncture Treatment on Alzheimers Disease in APOE e4 Carriers and Non-Carriers A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimers 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
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
Detailed Description:
This is a two-centre randomized controlled trial A total of 176 participants with mild-to-moderate Alzheimers disease 88 APOE e4 carriers and 88 non-carriers will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 11 The main acupoints are DU 24 EX-HN 3 DU 20 EX-HN 1 GB 12 HT 7 KI 6 GB39 There will be 12 weeks of 3-session treatment for each participant and a 52-week follow-up in total The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None