Subjective Cognitive Decline (SCD)NCT06758154
Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline
A study testing "TXJN" electro-acupuncture in people with Subjective Cognitive Decline (SCD), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Subjective Cognitive Decline (SCD)
- What is being tested?
- "TXJN" electro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for SCD diseases;
- 55-79 years old;
- ≥8 years of schooling;
- Right-handed;
- Sign the informed consent.
Who cannot join
- Have received other antidepressant therapy or involved in other clinical trials in the previous 2weeks.
- Infarct located in the left DLPFC.
- Positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc., in the past.
- 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.).
- Infection around acupoints and/or intolerance to acupuncture manipulation.
- MRI or rTMS contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Bing Zhang, 15851803070, zhangbing_nanjing@nju.edu.cn
About this study
Official title: Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline: A Multicenter Randomized Controlled Trial and fMRI Study
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.
- Conditions
- Subjective Cognitive Decline (SCD)
- Being tested
- "TXJN" electro-acupuncture, sham acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"TXJN" electro-acupunctureDevice
Firstly, EA treatment will be administered at the Neiguan (PC6, bilateral), Shenting(GV23), Yingxiang(LI20, bilateral), Yintang(GV29) acupoints. Disposable stainless-steel needles (0.25 mm × 25 mm; Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Suzhou City, China) will be used. After skin disinfection, the acupuncturists will twist and thrust the needle handles to achieve the sensations of achiness, heaviness, and numbness (known as de qi) at all above-mentioned acupoints. Following needle manipulations, EA instruments (SDZ-V, Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou City, China) will be used to attach the needle handles at PC6, GV23, LI20, GV29, with a dilatational wave of 5 Hz and a current intensity of 2 ~ 4 mA depending on the patient's tolerance. The needles will be removed after 30 min. Participants will receive 24 sessions over 8 weeks at a frequency of 3 times per week.
sham acupunctureDevice
Firstly, EA treatment will be administered at the non-acupoints near above-mentioned real acupoints. Disposable stainless-steel needles (0.25 mm × 25 mm; Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Suzhou City, China) will be used. After skin disinfection, the acupuncturists will take the needle into the acupoints without the sensations of de qi. Following needle manipulations, EA instruments (SDZ-V, Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou City, China) will be used to attach the needle handles at non-acupoints without the current. The needles will be removed after 30 min. Participants will receive 24 sessions over 8 weeks at a frequency of 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | True electroacupuncture Receives: Device: "TXJN" electro-acupuncture |
| Control group | Sham comparator | Sham electroacupuncture Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Z score
The neuropsychological scale of 8 objective cognitive assessments used in the study (including AVLT (S and L), AFT, BNT, TMT (A and B), SCWT-C, DSST, DST, CDT) was converted into Z scores for description. Specific operations: Standardize the score of a single cognitive domain scale, create the corresponding Z-score data set, calculate the average value of each data in the group to generate a single Z-score, and sum the Z-score of each single cognitive domain to generate the overall Z-score. Patients were evaluated before treatment and 8 weeks later.
Measured: Before and 8 weeks after treatment
Multimodal magnetic resonance imaging of olfactory related neural circuits
Structural MRI(3DTIWI/3DT2WI/3Dflair), functional MRI(BOLD\NODDI\ASL\ QSM)
Measured: Before and 8 weeks after treatment
Secondary outcomes (21)
mini-mental state examination, MMSE
Measured: Before and 8 weeks after treatment
Montreal Cognitive Assessment,MoCA
Measured: Before and 8 weeks after treatment
Subjective cognitive self-scoring
Measured: Before and 8 weeks after treatment
Hamilton Depression Scale，HAMD
Measured: Before and 8 weeks after treatment
the Geriatric Depression Scale,GDS
Measured: Before and 8 weeks after treatment
Hamilton Anxiety Scale,HAMA
Measured: Before and 8 weeks after treatment
auditory verbal learning test,AVLT
Measured: Before and 8 weeks after treatment
Rey complex figure test,CFT
Measured: Before and 8 weeks after treatment
Boston naming test,BNT
Measured: Before and 8 weeks after treatment
Animal fluency test,AFT
Measured: Before and 8 weeks after treatment
rail making test-A,TMT-A
Measured: Before and 8 weeks after treatment
rail making test-B,TMT-B
Measured: Before and 8 weeks after treatment
complex figure test, CFT
Measured: Before and 8 weeks after treatment
clock drawing test,CDT
Measured: Before and 8 weeks after treatment
Symbol Digit Modalities Test,SDMT
Measured: Before and 8 weeks after treatment
odor threshold test,OTT
Measured: Before and 8 weeks after treatment
The olfactory behavioral test
Measured: Before and 8 weeks after treatment
Spatial navigation behavior test
Measured: Before and 8 weeks after treatment
Pittsburgh sleep quality index,PSQI
Measured: Before and 8 weeks after treatment
TCM physique classification scale
Measured: Before and 8 weeks after treatment
TCM syndrome type scale of mild cognitive impairment
Measured: Before and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start28 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758154
- Sponsor's protocol ID
- 2024-050-01
- Status last verified
- Apr 2026
- First submitted
- 25 Dec 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline: A Multicenter Randomized Controlled Trial and fMRI Study
- ClinicalTrials.gov ID
- NCT06758154
- Acronym / sponsor ID
- 2024-050-01
- Conditions
- Subjective Cognitive Decline (SCD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: "TXJN" electro-acupunctureTrue electroacupuncture |
| Control group | Sham comparator | Device: sham acupunctureSham electroacupuncture |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria for SCD diseases;
- 55-79 years old;
- ≥8 years of schooling;
- Right-handed;
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Have received other antidepressant therapy or involved in other clinical trials in the previous 2weeks.
- Infarct located in the left DLPFC.
- Positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc., in the past.
- 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.).
- Infection around acupoints and/or intolerance to acupuncture manipulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "TXJN" electro-acupunctureFirstly, EA treatment will be administered at the Neiguan (PC6, bilateral), Shenting(GV23), Yingxiang(LI20, bilateral), Yintang(GV29) acupoints. Disposable stainless-steel needles (0.25 mm × 25 mm; Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Suzhou City, China) will be used. After skin disinfection, the acupuncturists will twist and thrust the needle handles to achieve the sensations of achiness, heaviness, and numbness (known as de qi) at all above-mentioned acupoints. Following needle manipulations, EA instruments (SDZ-V, Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou City, China) will be used to attach the needle handles at PC6, GV23, LI20, GV29, with a dilatational wave of 5 Hz and a current intensity of 2 ~ 4 mA depending on the patient's tolerance. The needles will be removed after 30 min. Participants will receive 24 sessions over 8 weeks at a frequency of 3 times per week. | Device | Experimental group |
| sham acupunctureFirstly, EA treatment will be administered at the non-acupoints near above-mentioned real acupoints. Disposable stainless-steel needles (0.25 mm × 25 mm; Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Suzhou City, China) will be used. After skin disinfection, the acupuncturists will take the needle into the acupoints without the sensations of de qi. Following needle manipulations, EA instruments (SDZ-V, Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou City, China) will be used to attach the needle handles at non-acupoints without the current. The needles will be removed after 30 min. Participants will receive 24 sessions over 8 weeks at a frequency of 3 times per week. | Device | Control group |
Primary outcome
Comprehensive Z score
Time frame: Before and 8 weeks after treatment
The neuropsychological scale of 8 objective cognitive assessments used in the study (including AVLT (S and L), AFT, BNT, TMT (A and B), SCWT-C, DSST, DST, CDT) was converted into Z scores for description. Specific operations: Standardize the score of a single cognitive domain scale, create the corresponding Z-score data set, calculate the average value of each data in the group to generate a single Z-score, and sum the Z-score of each single cognitive domain to generate the overall Z-score. Patients were evaluated before treatment and 8 weeks later.
Multimodal magnetic resonance imaging of olfactory related neural circuits
Time frame: Before and 8 weeks after treatment
Structural MRI(3DTIWI/3DT2WI/3Dflair), functional MRI(BOLD\NODDI\ASL\ QSM)
21 secondary outcomes
mini-mental state examination, MMSE
Time frame: Before and 8 weeks after treatment
Montreal Cognitive Assessment,MoCA
Time frame: Before and 8 weeks after treatment
Subjective cognitive self-scoring
Time frame: Before and 8 weeks after treatment
Hamilton Depression Scale，HAMD
Time frame: Before and 8 weeks after treatment
the Geriatric Depression Scale,GDS
Time frame: Before and 8 weeks after treatment
Hamilton Anxiety Scale,HAMA
Time frame: Before and 8 weeks after treatment
auditory verbal learning test,AVLT
Time frame: Before and 8 weeks after treatment
Rey complex figure test,CFT
Time frame: Before and 8 weeks after treatment
Boston naming test,BNT
Time frame: Before and 8 weeks after treatment
Animal fluency test,AFT
Time frame: Before and 8 weeks after treatment
rail making test-A,TMT-A
Time frame: Before and 8 weeks after treatment
rail making test-B,TMT-B
Time frame: Before and 8 weeks after treatment
complex figure test, CFT
Time frame: Before and 8 weeks after treatment
clock drawing test,CDT
Time frame: Before and 8 weeks after treatment
Symbol Digit Modalities Test,SDMT
Time frame: Before and 8 weeks after treatment
odor threshold test,OTT
Time frame: Before and 8 weeks after treatment
The olfactory behavioral test
Time frame: Before and 8 weeks after treatment
Spatial navigation behavior test
Time frame: Before and 8 weeks after treatment
Pittsburgh sleep quality index,PSQI
Time frame: Before and 8 weeks after treatment
TCM physique classification scale
Time frame: Before and 8 weeks after treatment
TCM syndrome type scale of mild cognitive impairment
Time frame: Before and 8 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "TXJN" electro-acupuncture in people with Subjective Cognitive Decline (SCD), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bing Zhang (15851803070, zhangbing_nanjing@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Z score (time frame: Before and 8 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.