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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Contact Information
Primary
Yijun Zhan
jenniferzhan_lhzj@163.com
+8618917699167
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 176
Treatments
Experimental: Acupuncture Treatment
Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks.
Active_comparator: Sham Acupuncture Treatment
Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Minimally Invasive Surgery Center
Leads: ZhanYJ

This content was sourced from clinicaltrials.gov