Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.

Zhejiang University

Status: Enrolling

Conditions: Alzheimer's Disease

Treatments: Device: Transcranial ultrasound stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05978830

Diagnosis and prognosis of AD

Details and patient eligibility

About

Developing and validating an early digitalized recognition device and multimodal warning model for Alzheimer's disease, and establishing a precision transcranial ultrasound stimulation intervention system.

Full description

1. Establishment of early digitalized recognition devices and multimodal warning models for AD: Participants undergo clinical assessments, and if they meet the inclusion criteria, their gender, age, MMSE, MoCA, CDR, GDS scores, as well as EEG ERP and MR data are collected. Eye-tracking analysis based on human-computer interaction perception technology, limb movement detection, and laser radar depth sensor fusion cognitive assessment are also performed simultaneously. After enrollment, follow-up assessments using scales (MMSE, MoCA, CDR, GDS, ADAS-cog, etc.) are conducted every six months, and EEG ERP and MR data are collected annually.
2. Construction of a precision transcranial ultrasound stimulation intervention system: Participants were randomly divided into true stimulation group and false stimulation group: true/false stimulation for 2 weeks, washout for 2 weeks, false/true stimulation for 2 weeks. After treatment, behavioral scale assessment, EEG ERP and multimodal MRI were performed to evaluate the therapeutic effect.

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with MCI / AD
2. Between the ages of 55 and 80
3. No history of mental illness such as schizophrenia, severe anxiety and depression

Exclusion criteria

1. Consistent with Parkinson's disease, frontotemporal dementia, dementia with lewy bodies Or Huntington's disease diagnostic criteria
2. Dementia due to other causes (e.g. cerebrovascular disease, central nervous system trauma, tumors, infections, Metabolic diseases, normal stress hydrocephalus, folic acid or vitamin B12 deficiency, hypothyroidism, etc.)
3. Have aphasia,Disorders that affect cognitive assessment, such as disorders of consciousness
4. Have a history of epilepsy or take antiepileptic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group 1

Experimental group

Description:

The group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks

Treatment:

Device: Transcranial ultrasound stimulation

Group 2

Sham Comparator group

Description:

The group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks

Treatment:

Device: Transcranial ultrasound stimulation