NCT03444896

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

February 4, 2018

Last Update Submit

June 13, 2019

Conditions

Subjective Cognitive DeclineSubjective Cognitive Complaint

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes from baseline at 12 weeks

Secondary Outcomes (1)

  • Neuroplasticity outcome

    baseline and 12 weeks

Other Outcomes (4)

  • The degree of complaint in cognitive decline

    baseline and 12 weeks

  • The sleep quality

    baseline and 12 weeks

  • The depressive symptoms

    baseline and 12 weeks

  • +1 more other outcomes

Study Arms (2)

Acupuncture group

EXPERIMENTAL
Device: Acupuncture group

Sham acupuncture group

PLACEBO COMPARATOR
Device: Sham acupuncture group

Interventions

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.

Acupuncture group
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.

Sham acupuncture group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 41351443DERIVED

  • Wang 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.

    PMID: 40007441DERIVED

  • Wang 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.

    PMID: 38521736DERIVED

  • Yan 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.

    PMID: 31601583DERIVED

Central Study Contacts

Liu c zhi, PHD

CONTACT

010-53912201lcz623780@126.com

Shi G xia, MD

CONTACT

010-53912201shiguangxia2008@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 4, 2018

First Posted

February 26, 2018

Study Start

April 25, 2018

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

CN(1)