Subjective Cognitive DeclineNCT03444896
The Efficacy and Mechanism of Acupuncture Treatment in Patients With Subjective Cognitive Decline
A study testing Acupuncture group in people with Subjective Cognitive Decline and Subjective Cognitive Complaint, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluates the efficacy and mechanism of acupuncture treatment in patients with subjective cognitive decline. Half of patients will receive acupuncture treatment for 12 weeks, while the other half will receive sham acupuncture treatment for 12 weeks . Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Subjective Cognitive Decline, Subjective Cognitive Complaint
- What is being tested?
- Acupuncture group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged 55-75;
- Native Chinese speakers with right-handed and at least a primary school education;
- Self-reported persistent memory decline, which was confirmed by caregivers;
- Normal general cognitive function and not meeting the criterion of mild cognitive impairment, as defined by performance within the normal range on both measures within at least one cognitive domain or in each of the three cognitive domains sampled (adjusted for age and education);
- No or minimal impairment in activities of daily living;
Who cannot join
- Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ;
- treatments that would affect cognitive function;
- Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression;
- Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer;
- History of alcohol or drug abuse/addiction in nearly two years;
- Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.);
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- Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations;
- Currently enrolled in another research study;
- Received acupuncture treatment in the preceding month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100029
Cun-Zhi Liu, PHD, 010-52176043, lcz623780@126.com
About this study
Official title: The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial
This study evaluates the efficacy and mechanism of acupuncture treatment in patients with subjective cognitive decline. Half of patients will receive acupuncture treatment for 12 weeks, while the other half will receive sham acupuncture treatment for 12 weeks .
- Being tested
- Acupuncture group, Sham acupuncture group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture groupDevice
Acupuncture needles were placed at acupoints Baihui (DU20), Shenting (DU24), Fengfu (DU16), Fengchi (GB20), Danzhong (RN17), Zhongwan (RN12), Qihai (RN6), Neiguan (PC6), Zusanli (ST36), Xuehai (SP10), Xinshu (BL15), Yixi (BL45), Tongli (HT5), and Zhaohai(KI6). Electrodes were attached the needle holders of the Baihui (DU20) and Shenting (DU24). The acupuncture needles are inserted through the adhesive pads and are retained for 20 minutes in every course. Treatment will be conducted over a period of 3 months, at a frequency of two times per week.
Sham acupuncture groupDevice
Sham acupoint (SA) 1 located in the midpoint of Shuaigu and Touwei. SA2 located in the midpoint of Touwei and Yangbai. SA3 located in the midpoint of Tianyou and Tianrong. SA4 located in 4 cun above umbilicus and 1 cun right of umbilical midline (UM). SA5 located in 2 cun below umbilicus and 1 cun right of UM. SA6 1 cun outside the point 1/4 of the line between Shenmen and Shaohai. SA7 located in 1 cun outside the midpoint of Shaohai and Tongli. SA8 located in 6 cun above mediosuperior border of the patella. SA9 located in 3 cun below the Yanglingquan and middle of the gallbladder and bladder channels. SA10 located in midpoint between Jiexi and Qiuxu. SA11 and SA12 located in 2 cun from the lower border of spinous process of fifth or sixth thoracic vertebra. Electrodes were attached the needle holders of the bilateral SA 2. Procedures, and other treatment settings were the same in the acupuncture group but with no skin penetration, electricity output, or needle manipulation for de qi.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Not described Receives: Device: Acupuncture group |
| Sham acupuncture group | Placebo comparator | Not described Receives: Device: Sham acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
A composite score will be computed by averaging z-scores from Animal Fluency Test, Digit Symbol Substitution Test, Trail-Making Test Parts A and B, Stroop Color Word Test C, Digit Span Test, Boston Naming Test, Clock Drawing Test and Auditory Verbal Learning Test delayed recall and delayed recognition.
Measured: Changes from baseline at 12 weeks
Secondary outcomes (1)
Neuroplasticity outcome
Neuroplasticity outcome changes are measured by structural MRI (including DTI), task functional MRI, resting state functional MRI and arterial spin labeling.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start25 Apr 2018
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Zhou, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444896
- Sponsor's protocol ID
- 2017BL-061-03
- Status last verified
- Jun 2019
- First submitted
- 4 Feb 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou H, Wang L, Wei XY, Lee CK, Wang ZY, Yan CQ, Liu CZ, Wang X, Shi GX. Brain Connectivity and Topological Reorganization of Multiple Functional Networks in Subjective Cognitive Decline After Acupuncture Intervention: A Secondary Analysis of a Randomized Controlled Trial. J Integr Neurosci. 2025 Nov 27;24(11):45003. doi: 10.31083/JIN45003.
PubMed 41351443Wang L, Su XT, Yang NN, Wang QY, Yang JW, Liu CZ. Electroacupuncture improves cerebral blood flow in pMCAO rats during acute phase via promoting leptomeningeal collaterals. J Cereb Blood Flow Metab. 2025 Aug;45(8):1507-1518. doi: 10.1177/0271678X241270240. Epub 2025 Feb 26.
PubMed 40007441Wang X, Zhou H, Yan CQ, Shi GX, Zhou P, Huo JW, Yang JW, Zhang YN, Wang L, Cao Y, Liu CZ. Cognitive and Hippocampal Changes in Older Adults With Subjective Cognitive Decline After Acupuncture Intervention. Am J Geriatr Psychiatry. 2024 Aug;32(8):1014-1027. doi: 10.1016/j.jagp.2024.03.001. Epub 2024 Mar 7.
PubMed 38521736Yan CQ, Zhou P, Wang X, Tu JF, Hu SQ, Huo JW, Wang ZY, Shi GX, Zhang YN, Li JQ, Wang J, Liu CZ. Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial. BMJ Open. 2019 Oct 10;9(10):e028317. doi: 10.1136/bmjopen-2018-028317.
PubMed 31601583
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03444896
- Acronym / sponsor ID
- 2017BL-061-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 26 Feb 2018 (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.
This study evaluates the efficacy and mechanism of acupuncture treatment in patients with subjective cognitive decline. Half of patients will receive acupuncture treatment for 12 weeks, while the other half will receive sham acupuncture treatment for 12 weeks .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: Acupuncture group |
| Sham acupuncture group | Placebo comparator | Device: Sham acupuncture group |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults aged 55-75;
- Native Chinese speakers with right-handed and at least a primary school education;
- Self-reported persistent memory decline, which was confirmed by caregivers;
- Normal general cognitive function and not meeting the criterion of mild cognitive impairment, as defined by performance within the normal range on both measures within at least one cognitive domain or in each of the three cognitive domains sampled (adjusted for age and education);
- No or minimal impairment in activities of daily living;
Key exclusion criteria (9 listed)
- Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ;
- treatments that would affect cognitive function;
- Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression;
- Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer;
- History of alcohol or drug abuse/addiction in nearly two years;
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 |
|---|---|---|
| Acupuncture groupAcupuncture needles were placed at acupoints Baihui (DU20), Shenting (DU24), Fengfu (DU16), Fengchi (GB20), Danzhong (RN17), Zhongwan (RN12), Qihai (RN6), Neiguan (PC6), Zusanli (ST36), Xuehai (SP10), Xinshu (BL15), Yixi (BL45), Tongli (HT5), and Zhaohai(KI6). Electrodes were attached the needle holders of the Baihui (DU20) and Shenting (DU24). The acupuncture needles are inserted through the adhesive pads and are retained for 20 minutes in every course. Treatment will be conducted over a period of 3 months, at a frequency of two times per week. | Device | Acupuncture group |
| Sham acupuncture groupSham acupoint (SA) 1 located in the midpoint of Shuaigu and Touwei. SA2 located in the midpoint of Touwei and Yangbai. SA3 located in the midpoint of Tianyou and Tianrong. SA4 located in 4 cun above umbilicus and 1 cun right of umbilical midline (UM). SA5 located in 2 cun below umbilicus and 1 cun right of UM. SA6 1 cun outside the point 1/4 of the line between Shenmen and Shaohai. SA7 located in 1 cun outside the midpoint of Shaohai and Tongli. SA8 located in 6 cun above mediosuperior border of the patella. SA9 located in 3 cun below the Yanglingquan and middle of the gallbladder and bladder channels. SA10 located in midpoint between Jiexi and Qiuxu. SA11 and SA12 located in 2 cun from the lower border of spinous process of fifth or sixth thoracic vertebra. Electrodes were attached the needle holders of the bilateral SA 2. Procedures, and other treatment settings were the same in the acupuncture group but with no skin penetration, electricity output, or needle manipulation for de qi. | Device | Sham acupuncture group |
Primary outcome
Change in cognitive function
Time frame: Changes from baseline at 12 weeks
A composite score will be computed by averaging z-scores from Animal Fluency Test, Digit Symbol Substitution Test, Trail-Making Test Parts A and B, Stroop Color Word Test C, Digit Span Test, Boston Naming Test, Clock Drawing Test and Auditory Verbal Learning Test delayed recall and delayed recognition.
1 secondary outcome
Neuroplasticity outcome
Time frame: baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Derived from this study: PubMed 41351443Zhou H, Wang L, Wei XY, Lee CK, Wang ZY, Yan CQ, Liu CZ, Wang X, Shi GX. Brain Connectivity and Topological Reorganization of Multiple Functional Networks in Subjective Cognitive Decline After Acupuncture Intervention: A Secondary Analysis of a Randomized Controlled Trial. J Integr Neurosci. 2025 Nov 27;24(11):45003. doi: 10.31083/JIN45003.
- Derived from this study: PubMed 40007441Wang L, Su XT, Yang NN, Wang QY, Yang JW, Liu CZ. Electroacupuncture improves cerebral blood flow in pMCAO rats during acute phase via promoting leptomeningeal collaterals. J Cereb Blood Flow Metab. 2025 Aug;45(8):1507-1518. doi: 10.1177/0271678X241270240. Epub 2025 Feb 26.
- Derived from this study: PubMed 38521736Wang X, Zhou H, Yan CQ, Shi GX, Zhou P, Huo JW, Yang JW, Zhang YN, Wang L, Cao Y, Liu CZ. Cognitive and Hippocampal Changes in Older Adults With Subjective Cognitive Decline After Acupuncture Intervention. Am J Geriatr Psychiatry. 2024 Aug;32(8):1014-1027. doi: 10.1016/j.jagp.2024.03.001. Epub 2024 Mar 7.
- Derived from this study: PubMed 31601583Yan CQ, Zhou P, Wang X, Tu JF, Hu SQ, Huo JW, Wang ZY, Shi GX, Zhang YN, Li JQ, Wang J, Liu CZ. Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial. BMJ Open. 2019 Oct 10;9(10):e028317. doi: 10.1136/bmjopen-2018-028317.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture group in people with Subjective Cognitive Decline and Subjective Cognitive Complaint, run by Beijing Hospital of Traditional Chinese Medicine 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 9 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: status not confirmed, as of the sponsor's last update on 17 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu c zhi, PHD (010-53912201, lcz623780@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: Changes from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444896, which also lists 4 linked publications.
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 17 Jun 2019.