NCT06758154 Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline
| NCT ID | NCT06758154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Subjective Cognitive Decline (SCD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-12-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2024-12-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Meet the diagnostic criteria for SCD diseases; 2. 55-79 years old; 3. ≥8 years of schooling; 4. Right-handed; 5. Sign the informed consent. Exclusion Criteria: 1. Have received other antidepressant therapy or involved in other clinical trials in the previous 2weeks. 2. Infarct located in the left DLPFC. 3. Positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc., in the past. 4. Other serious concomitant diseases (aphasia, severe edema, venous thrombosis, arteriosclerosis occlusion, diabetic vascular disease, peripheral neuropathy, spinal lesions, brain trauma, intracranial infection, brain tumors, etc.) or secondary diseases (heart, liver, renal failure, etc.). 5. Infection around acupoints and/or intolerance to acupuncture manipulation. 6. MRI or rTMS contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06758154 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 79 Years, studying Subjective Cognitive Decline (SCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06758154 currently recruiting?
Yes, NCT06758154 is actively recruiting participants. Contact the research team at zhangbing_nanjing@nju.edu.cn for enrollment information.
Where is the NCT06758154 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06758154 clinical trial?
NCT06758154 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 92 participants.