Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

NCT04804618 | Recruiting DMC

• 1 other identifier: AD2020
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer Disease, Early Onset; Protein; Disease

Keywords

Alzheimer Disease; biomarker; protein

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Change of the cognitive function every year

  An Average of 1 year

• Changes in plasma protein expression profile every year

  An Average of 1 year

• Variation characteristics of gut microbiome every year

  An Average of 1 year

Study Arms (4)

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Guangzhou Cadre Health Management Center: collaborator

Study Sites (1)

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Alzheimer Disease; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

jianwen guo, Dr

CONTACT

13724899379; 306247680@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 18, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (1)