Clinical trial NCT03444896: The Efficacy and Mechanism of Acupuncture Treatment in Patients With Subjective Cognitive Decline
Official title: The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjective Cognitive Decline
Subjective Cognitive Complaint
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Change in cognitive function
timeFrame: Changes from baseline at 12 weeks
Secondary outcomes:
measure: Neuroplasticity outcome
timeFrame: baseline and 12 weeks
Other outcomes:
measure: The degree of complaint in cognitive decline
timeFrame: baseline and 12 weeks
measure: The sleep quality
timeFrame: baseline and 12 weeks
measure: The depressive symptoms
timeFrame: baseline and 12 weeks
measure: The face recognition ability and sense of direction
timeFrame: baseline and 12 weeks
Locations:
city: Beijing
country: China
facility: School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
state: Beijing
Study officials:
References:
citation: 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.