Study on Aging and Cognitive Impairment in China

NCT06679296 | Recruiting DMC

• 1 other identifier: weihongsong2024
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: By the end of 2022, China had about 280 million people aged 60 and older, making up 19.8% of the population. This number is projected to exceed 300 million by the end of the 14th Five-Year Plan and 400 million by 2035, which would be over 30%. The 20th National Congress emphasized the need for a proactive strategy to tackle aging challenges. Approximately 6.04% of the elderly have dementia, with 3.94% having Alzheimer's disease. This totals around 15 million people with dementia. To address this, the China Cohort Consortium on Aging and Cognitive Impairment Development has been proposed to study health and cognitive changes in different age groups, aiming to support healthy aging policies. Methods: Participants from various age groups (children, youth, middle-aged, elderly) will be recruited from hospitals, schools, and communities using stratified sampling. They will undergo detailed medical examinations focusing on aging, cognitive impairments, and related diseases. A new database will track healthy aging and cognitive impairment development. Content: The study will involve comprehensive medical examinations, including physiological assessments, psychological evaluations, cognitive screenings, daily life assessments, imaging studies, and blood tests, to establish a detailed health and cognitive impairment database. The research will also investigate integrated intervention models in hospital, community, and home settings, develop remote medical management systems, and devise biomarker test kits for aging and cognitive impairments. Furthermore, it will concentrate on non-pharmacological interventions and artificial intelligence systems for the early detection, prevention, and treatment of aging-related conditions. Objectives: The China Cohort Consortium on Aging and Cognitive Impairment Development, commencing with the HAPCAD study, aims to monitor changes across various age groups, evaluate the impact of aging on health and cognitive function, and design targeted interventions. The objective is to enhance health management and services related to aging, establish effective strategies, develop therapeutic drugs, and promote healthy aging.

Conditions

Cognitive Dysfunction; Aging

Keywords

Cognitive dysfunction; aging; Alzheimer disease

Outcome Measures

Primary Outcomes (2)

• Assessing the prevalence of cognitive impairment in China based on MMSE, MoCA and CDR.

  The statement involves evaluating the prevalence of cognitive impairment in China using three assessment tools: the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), and the Clinical Dementia Rating (CDR). MMSE: This test has a maximum score of 30 points, with scores below 24 typically indicating cognitive impairment. MoCA: The MoCA also has a maximum score of 30 points, where a score of 26 or lower indicates cognitive impairment. CDR: The CDR uses a scale from 0 to 3, where 0 indicates no cognitive impairment, 0.5 suggests mild cognitive impairment, 1 denotes mild dementia, 2 indicates moderate dementia, and 3 reflects severe dementia.

  through study completion, an average of 5 year.

• Change in Alzheimer disease biomarkers over time

  Aβ, t-tau and p-tau levels in pg/ml

  through study completion, an average of 3 year.

Secondary Outcomes (4)

• Changes of brain structure at different stage of cognitive impairment in Alzheimer disease in China.

  through study completion, an average of 5 year.

• Changes of brain glucose metabolism at different stage of cognitive impairment in Alzheimer disease in China.

  through study completion, an average of 3 year.

• Changes of brain amyloid deposition at different stage of cognitive impairment in Alzheimer disease in China.

  through study completion, an average of 3 year.

• Changes of brain tau deposition at different stage of cognitive impairment in Alzheimer disease in China.

  through study completion, an average of 3 year.

Other Outcomes (13)

• Changes in Lifestyle factors over time: Smoking

  Measured at Baseline, year 1, year3, year 5, year 10

• Changes in Lifestyle factors over time: Alcohol Consumption

  Measured at Baseline, year 1, year3, year 5, year 10

• Changes in Lifestyle factors over time: drug abuse/misuse

  Measured at Baseline, year 1, year3, year 5, year 10

Study Arms (1)

Observation group

Establish a screening and long-term tracking cohort study related to healthy aging and the development of cognitive impairments to understand changes in physiological, psychological, mental, and daily living abilities across different age groups in humans. Analyze genetic factors, environmental influences, lifestyle, and their impacts on the occurrence and development of healthy aging, cognitive impairments, and other age-related diseases.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is sourced from communities, hospitals, and healthy volunteers. There is no requirement for randomization of study subjects at enrollment. However, during further testing and analysis, one or more researchers select appropriate case samples for grouping and blinding assessors, and analysts is implemented to prevent bias.

You may qualify if:

• Ability to sign an informed consent form: Participants and/or their legally authorized representatives, in case of diminished decision-making capacity, are capable of reading, understanding, and providing written informed consent as per national legal requirements.
• Capability to complete assessments independently or with assistance.
• Willingness and ability to fulfill all study requirements, including peripheral organ function assessments, EEG, lumbar puncture, MRI, and PET imaging examinations.
• Agreement to participate in follow-up visits.

You may not qualify if:

• Terminal stage of significant diseases such as malignant tumors or autoimmune diseases at enrollment;
• Substance abusers.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• Wenzhou Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 32500, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (Serum, Plasma, Whole Blood, RNA, DNA) Urine Saliva CSF

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Weihong Song Prof.

  First Affiliated Hospital of Wenzhou Medical University

  STUDY CHAIR

Central Study Contacts

Sipei Pan Dr.

CONTACT

86+13758710622; pansipei@wmu.edu.cn

Qin-Fen Chen Dr.

CONTACT

86+15167735852; chenqinfen@wmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: November 7, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)