Clinical trial NCT05978830: Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.
Official title: The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Keywords: EEG
MRI
Digital intelligence equipment
Machine learning
microstate
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cognitive assessment was performed by neuropsychological professionals before and after each treatment, and treatment was performed with real and fake stimuli Multimodal MRI was performed again 2 days later. (1) Subjects in one group received Active Transcranial ultrasound stimulation for 2 weeks ; The other group received Sham Transcranial ultrasound stimulation for 2 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Power spectrum
timeFrame: 6 months
measure: Duration of microstate
timeFrame: 6 months
measure: Occurrence of microstate
timeFrame: 6 months
measure: Mini-Mental State Examination (MMSE)
timeFrame: 6 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yi Ling
state: Zhejiang
Study officials:
affiliation: Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University
name: benyan luo, Pro
role: STUDY_CHAIR
References: