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Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline: A Multicenter Randomized Controlled Trial and fMRI Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Subjective cognitive decline (SCD) is the early diagnosis and treatment window period of Alzheimer's disease (AD), and the identification of SCD individuals who will progress to AD (pSCD) is a research hotspot. Based on olfactory fMRI,previous studies have found that SCD individuals showed damaged entorhinal neural circuits. After follow-up, the incidence of pSCD increased by three times. But,the spatiotemporal characteristics of the entorhinal neural circuits and whether it has the value of individualized prediction and intervention target need to be further studied. Thus, based on multi-center ambispective cohort study at home and abroad, we will (1) build a new paradigm of synchronous fMRI-EEG olfactory task state Oddball experiment, jointly representational similarity analysis, extract spatiotemporal characteristics of neural circuits damage, and discover and verify that the entorhinal neural circuits are vulnerable brain regions; (2) establish the middle fusion model of vulnerable brain region combined with the methods of olfactory task-fMRI activation image generation, functional connectome gradient,etc.; Then, establish late fusion multi-omics multi-task model combined with the new methods of molecularomics such as ultra-deep total proteomics and metabonomics proposed by the research group to accurately identify pSCD; (3) carry out the precise intervention of image-guided olfactory three-needle acupuncture with the entorhinal neural circuits as the target. Through clinical RCT research and mouse model, the remodeling mechanism of vulnerable brain regions will be clarified.This project will provide the basis for early diagnosis and treatment of the AD risk population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 79
Healthy Volunteers: f
View:

• Meet the diagnostic criteria for SCD diseases;

• 55-79 years old;

• ≥8 years of schooling;

• Right-handed;

• Sign the informed consent.

Locations
Other Locations
China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Contact Information
Primary
Bing Zhang
zhangbing_nanjing@nju.edu.cn
15851803070
Time Frame
Start Date: 2024-12-28
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 92
Treatments
Experimental: Experimental group
True electroacupuncture
Sham_comparator: Control group
Sham electroacupuncture
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov