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A clinical study on the safety and efficacy of a wearable device for treating Alzheimer's disease.

A clinical study on the safety and efficacy of a wearable device for treating Alzheimer's disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001451
Enrollment
Unknown
Registered
2026-06-10
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Alzheimer's Disease

Interventions

Control Group:Acupuncture
Experimental group:Wearable Patent Combined Acupuncture Therapy

Sponsors

Beijing University of Chinese Medicine Second Affiliated Clinical Hospital Oriental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Meets diagnostic criteria; 2. Aged =50 years; 3. Mini-Mental State Examination (MMSE) screening and baseline scores must be between 9 and 26 (inclusive) (i.e., mild to moderate patients) (assessed by two neurologists or one neurologist with a senior associate title or above); 4. Hasegawa Dementia Scale (HDS) scores must be between 0 and 10 (inclusive) (assessed by two neurologists or one neurologist with a senior associate title or above); 5. Clinical Dementia Rating (CDR) scores must be 1 or 2 (assessed by two neurologists or one neurologist with a senior associate title or above); 6. Montreal Cognitive Assessment (MoCA) scores must be less than 26 (exclusive) (assessed by two neurologists or one neurologist with a senior associate title or above); 7. Has not changed Alzheimer's disease-related treatments in the past month; 8. Agrees to remain in the treatment area during the study period; 9. Voluntarily agrees to participate in this study and signs the informed consent form (if the participant is unable to sign the informed consent form independently, a legally authorized representative may sign the proxy consent form).

Exclusion criteria

Exclusion criteria: (1) Negative for Aß and neuronal injury biomarkers (P-Tau217 in this trial) in blood; (2) Hachinski Ischemic Scale (HIS) score =5 points (assessed by two neurologists or one neurologist with a senior associate title or above), i.e., non-AD dementia patients; patients with potential neurologic diseases causing dementia (e.g., normal pressure hydrocephalus, subdural hematoma) or patients with Parkinson's disease or vascular dementia; (3) Significant concomitant cerebrovascular diseases, such as a history of stroke associated with the onset or worsening of cognitive impairment; or the presence of multiple or extensive infarcts, or severe white matter hyperintensity burden; (4) Core features of Lewy body dementia, in addition to dementia itself; (5) Prominent features of behavioral variant frontotemporal dementia; (6) Prominent features of semantic variant primary progressive aphasia or non-fluent primary progressive aphasia; (7) Evidence of another concurrent active neurologic disease, or non-neurologic medical comorbidities, or use of medications that may have a major impact on cognition; (8) Core features of diagnoses overlapping with AD, such as HIV dementia, syphilitic dementia, Huntington's disease dementia, or other causes of dementia; (9) Core features of cognitive impairment caused by folate or vitamin B12 abnormalities; (10) Core features of cognitive impairment caused by chronic moderate alcoholism; (11) Congenital disabilities, skin diseases, or injuries in the head or acupuncture areas; (12) Presence of another severe disease that is not well-controlled; (13) Unable to walk or assist in walking (e.g., using a wheelchair, walker, or cane); visual or hearing impairments that prevent adherence to the testing procedures (e.g., wearing glasses or hearing aids); (14) Presence of contraindications for MRI; (15) Participation in other clinical trials simultaneously.

Design outcomes

Primary

MeasureTime frame
Mini-Mental State Examination Scale;Clinical Dementia Rating Scale;Montreal Cognitive Assessment Scale;Hasegawa Dementia Scale;Alzheimer's Disease Cognitive Assessment Scale;

Secondary

MeasureTime frame
Inflammatory Factor Metabolism;Plasma Acetylcholine Related Indicators;MRI Detection of Amygdala and Hippocampal Regions NAA/Cr Ratio - Functional Imaging Sequence;Plasma glial fibrillary acidic protein;

Countries

China

Contacts

Public ContactQin WeiLan

Beijing University of Chinese Medicine Second Affiliated Clinical Hospital Oriental Hospital/Beijing University of Chinese Medicine Second Affiliated Clinical Hospital Oriental Hospital

wlqin@qq.com15801557812

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026