Proteomics Study of Mild Cognitive Impairment and Alzheim... | NCT04804618

Studies
Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

NCT04804618

Sponsor

Guangzhou University of Traditional Chinese Medicine

Status

Unknown status

Last Update Posted

Nov 15, 2022Actual

Enrollment

650Estimated

Phase

Not provided

Conditions

Alzheimer Disease, Early Onset
Protein; Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Feb 20, 2021

First Submission Date that Met QC Criteria

Mar 15, 2021

First Posted Date

Mar 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2022

Last Update Posted Date

Nov 15, 2022Actual

Name	Class
Guangzhou Cadre Health Management Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

Detailed Description

The problem of population aging is getting worse, the prevalence of senile dementia is increasing, and Alzheimer's disease (AD) is the most common type of dementia. There is no effective treatment for AD. Most interventions can only alleviate the condition and delay the development. Therefore, early diagnosis and prevention of AD are extremely important. However, the current diagnostic measures are not suitable for clinical promotion due to their traumatic nature, so there is an urgent need for a more suitable clinical early identification and diagnosis method. Proteomics research technology is the leading research technology in China. It can be applied to research on disease markers, pathogenesis, and drug target discovery.

Therefore, this study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

650Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy control group		aged ≥55 years old, no dementia, MCI or no family history of AD.
Alzheimer's disease high-risk group		aged ≥55 years old, immediate family members of AD patients
Alzheimer's disease group		aged ≥55 years old, diagnosed as AD patients
Mild cognitive impairment group		patients ≥55 years of age, diagnosed with MCI

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the protein expression profile of urine and saliva	Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.	An Average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Change of the cognitive function every year	Mini-mental State Examination (MMSE) score for the the cognitive function assessment. The total score in MMSE ranges from 0 to 30, and higher scores indicate better cognition.	An Average of 1 year
Changes in plasma protein expression profile every year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 55-year-old，male or female.
patients meet the diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease(AD) or whose family members were diagnoed with AD
Complete self-rating scale for memory impairment (AD-8 scale)
Those who agree to participate in clinical research and sign informed consent.

Exclusion Criteria:

Patients with acute cardiovascular and cerebrovascular diseases, acute infections (pneumonia, urinary tract infection, oral infection, digestive tract infection), severe renal dysfunction, and uremia;
Pregnant or lactating women;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From March 2021 to March 2022，people who finish the cognitive examination at Guangdong Provincial Hospital of Chinese Medicine and the Guangzhou Cadre Health Management Center would be this study population. All the eligible participants will be follow up every year until 2026.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
jianwen guo, Dr	Contact	13724899379		306247680@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Province Hospital of Tradtional Chinese Medicine	Recruiting	Guangzhou	Guangdong	510120	China

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D004194	Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

All biological specimens (including blood, feces, urine, saliva and tongue coating) will be stored in the biological resource center of the our research centers after written informed consent obtained from all subjects who voluntarily participated in this clinical study.