Skip to content

A Randomized Controlled Study on the Regulation of the GABAergic System Using sedative-tranquilizing acupuncture Based on the 'Three-Factor Theory' for Treating Insomnia with Alzheimer's Disease-Related Mild Cognitive Impairment

A Randomized Controlled Study on the Regulation of the GABAergic System Using sedative-tranquilizing acupuncture Based on the 'Three-Factor Theory' for Treating Insomnia with Alzheimer's Disease-Related Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001057
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Acupuncture group:Needling the four Shencong points and the two Hou'er points 15mm perpendicularly against the Du meridian
needling 1.5 cun beside the left and right points of Baihui along the Bladder meridian, 15mm perpendicularly, all to beneath the epicranial aponeurosis, with small amplitude rapid rotation
needling Shenmen along the Heart meridian 13-14mm, Sanyinjiao perpendicularly 15-20mm, both points with even tonifying and reducing, evenly lifting, thrusting, and rotating, to the degree of mild sore
Sham acupuncture group:For the Cibai point, 0.5 cun lateral to the anterior and posterior points, needle perpendicularly on the Governing Vessel to a depth of 15mm
for the left and right points, 0.5 cun lateral to them, needle perpendicularly along the Bladder meridian to a depth of 15mm
Shenmen point, needle perpendicularly to a depth of 13-14mm
Sanyinjiao on the forearm, locate at the radial side of the flexor carpi ulnaris tendon on the palmar side, 2 cun above the transverse wrist crease, needle opposite to the Heart meridian to a depth of
Sanyinjiao on the lower leg, 4 cun above the tip of the medial malleolus, needle perpendicularly to a depth of 15-20mm
during Chen hour (7:00-9:00 pm), needle retention for 30 minutes per session, 3 sessions per week, for a total of 4 weeks.
Waiting treatment group:No acupuncture treatment is accepted during the study period. If MMSE is between 10 and 20 points, donepezil hydrochloride is used at 5 mg per dose per day
if PSQI is =12 points, use zopiclone, adjusting the dose according to severity at 1–3 mg per night until symptoms improve.

Sponsors

Nanchang Hongdu Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for insomnia according to the 3rd edition of the International Classification of Sleep Disorders (ICSD-3) by the American Academy of Sleep Medicine: age 18–65 years; Pittsburgh Sleep Quality Index (PSQI) =7 points; HAMA anxiety self-rating scale score =7 points; voluntarily participates in this trial and signs the informed consent form; no use of benzodiazepines, melatonin, or other related drugs in the 1–3 weeks prior to screening. (2) Meets the diagnostic criteria for 'AD-related MCI' as proposed in the 2024 China Expert Consensus on the Diagnosis and Treatment of Alzheimer's Disease-Related Mild Cognitive Impairment: memory decline complaint =6 months; preserved activities of daily living (ADL = 23/26); MoCA score 18–26 points; CDR = 0.5; has not yet reached the stage of dementia.

Exclusion criteria

Exclusion criteria: (1) MCI caused by vascular factors, Lewy bodies, frontotemporal lobe, or Parkinson's disease; Hachinski ischemic score >4; (2) Severe OSA (AHI =15), RLS, circadian rhythm disorders, REM sleep behavior disorder; (3) Individuals with severe heart, liver, or kidney dysfunction, or pregnant or breastfeeding women, who are not suitable for acupuncture treatment; (4) History of brain trauma, intracranial space-occupying lesions, epilepsy, or metal implants in the head; (5) Use of sedative-hypnotic drugs or acupuncture treatment within the past month; (6) Patients with needle phobia or intolerance to acupuncture; (7) Patients with skin infection or inflammation in the planned acupuncture points area.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Alzheimer's Disease Assessment Scale-Cognitive subscale;

Secondary

MeasureTime frame
Montreal Cognitive Assessment;Hamilton Anxiety Scale;Patient satisfaction;Plasma GABA;polysomnography;Magnetic Resonance Pop;

Countries

China

Contacts

Public ContactLiziqing

Nanchang Hongdu Hospital of Traditional Chinese Medicine

liziqing100@yeah.net18307004910

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026