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

B

Beijing Hospital of Traditional Chinese Medicine

Status

Unknown

Conditions

Subjective Cognitive Complaint
Subjective Cognitive Decline

Treatments

Device: Acupuncture group
Device: Sham acupuncture group

Study type

Interventional

Funder types

Other

Identifiers

NCT03444896
2017BL-061-03

Details and patient eligibility

About

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 .

Enrollment

60 estimated patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Acupuncture group
Experimental group
Treatment:
Device: Acupuncture group
Sham acupuncture group
Placebo Comparator group
Treatment:
Device: Sham acupuncture group

Trial contacts and locations

1

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Central trial contact

Liu c zhi, PHD; Shi G xia, MD

Data sourced from clinicaltrials.gov

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