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

Alzheimer's Disease Clinical Trial

Official title:

The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978830
• Other study ID #: Diagnosis and prognosis of AD
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Yi Ling, Dr
• Phone: 15168236137
• Email: 12118458[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• Transcranial ultrasound stimulation
In each active/sham-ultrasound stimulation experiment, subjects first underwent two baseline motor evoked potential (MEP) tests, with an interval of 15 minutes between the two baseline tests. After 15 minutes of true/pseudo-transcranial ultrasound stimulation, subjects immediately underwent a MEP test, and then 15 minutes later, subjects underwent another MEP test. The MEP was tested again 15 minutes later.

Locations

Country	Name	City	State
China	Yi Ling	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Power spectrum	The investigators collected EEG data of participants in resting state and listening to music and the absolute power spectral density values (alpha,beta,theta,delta bands dB/Hz) will be calculated using spectral analysis.	6 months
Primary	Duration of microstate	The investigators refined the microstate method to accurately estimate topographical differences. The calculations were performed for measures of duration (ms). The duration of each microstate were utilized to predict disease classification and prognosis evaluation for patients with Alzheimer's disease.	6 months
Primary	Occurrence of microstate	The investigators refined the microstate analysis. The calculations were performed for measures of occurrence (times per minute). The occurrence of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.	6 months
Primary	Mini-Mental State Examination (MMSE)	MMSE includes a series of questions and tasks to assess the individual's memory, attention, calculation, language, spatial, and executive functions. The test items include recalling instructions, reproducing patterns, performing mathematical calculations, naming objects, writing sentences, etc. Each item has different scoring criteria, and scores are assigned based on the participant's responses and performance. The total score is 30, with higher scores indicating better cognitive functioning.	6 months
Primary	Montreal Cognitive Assessment (MoCA)	MoCA is a standardized assessment tool used to evaluate cognitive function, particularly for early cognitive impairment and mild cognitive impairment. It consists of a series of questions and tasks that cover areas such as memory, attention, executive functions, language, and spatial abilities. Test items include naming animals, drawing a clock, recalling a sequence, task guidance, etc., and each item is assigned a different score. The score range is from 0 to 30, with higher scores indicating better cognitive function.	6 months