The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial

Beijing Hospital of Traditional Chinese Medicine1 site in 1 country60 target enrollmentApril 25, 2018

ConditionsSubjective Cognitive Decline Subjective Cognitive Complaint

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Subjective Cognitive Decline
Sponsor: Beijing Hospital of Traditional Chinese Medicine
Enrollment: 60
Locations: 1
Primary Endpoint: Change in cognitive function
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 .

Registry

clinicaltrials.gov

Start Date

April 25, 2018

End Date

March 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Hospital of Traditional Chinese Medicine

Responsible Party

Principal Investigator

Ping Zhou

doctor

Beijing Hospital of Traditional Chinese Medicine

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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.