The Efficacy and Mechanism of Acupuncture Treatment in Patients With Subjective Cognitive Decline

Not Applicable

• Conditions: Subjective Cognitive Decline; Subjective Cognitive Complaint
• Interventions: Device: Acupuncture group; Device: Sham acupuncture group

• Registration Number: NCT03444896
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Study Start: 2018-04-25
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17
• Primary Completion: 2020-01
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male and female adults aged 55-75;
2. Native Chinese speakers with right-handed and at least a primary school education;
3. Self-reported persistent memory decline, which was confirmed by caregivers;
4. 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);
5. No or minimal impairment in activities of daily living;

Exclusion Criteria

1. Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ;
2. treatments that would affect cognitive function;
3. Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression;
4. Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer;
5. History of alcohol or drug abuse/addiction in nearly two years;
6. Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.);
7. Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations;
8. Currently enrolled in another research study;
9. Received acupuncture treatment in the preceding month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture group	-
Sham acupuncture group	Sham acupuncture group	-

Primary Outcome Measures

Name	Time	Method
Change in cognitive function	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.

Secondary Outcome Measures

Name	Time	Method
Neuroplasticity outcome	baseline and 12 weeks	Neuroplasticity outcome changes are measured by structural MRI (including DTI), task functional MRI, resting state functional MRI and arterial spin labeling.

Trial Locations

Locations (1)

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China