Greater-Bay-Area Healthy Aging Brain Study (GHABS)

NCT06183658 | Recruiting DMC

• 1 other identifier: YL2023-001
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the pathophysiology characterization and evolutionary patterns of Alzheimer's disease (AD) in South China older adults. The primary purposes are as follows:

1. 1.The prevalence and characteristics of AD in South China's aging population
2. 2.Identify novel biomarkers and neuroimaging techniques for early detection and intervention of AD
3. 3.Supporting and fertilizing novel approaches and techniques for early diagnosis and intervention of AD Participants will undergo cognitive assessments, blood sample collection, and genetic testing. Some will undergo CSF collection, stool sample collection, MRI scanning, Aβ PET scanning, and tau PET scanning.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (10)

• Longitudinal changes of cognitive function _ ADAS-Cog

  Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

  An average of 1 year

• Longitudinal changes of cognitive function _ MMSE, the Chinese version

  Mini-mental State Examination (MMSE, the Chinese version)

  An average of 1 year

• Longitudinal changes of cognitive function _ MoCA-Basic

  Montreal Cognitive Assessment Basic (MoCA-Basic)

  An average of 1 year

• Longitudinal functional and behavioral function _ CDR

  Clinical Dementia Rating (CDR)

  An average of 1 year

• Longitudinal functional and behavioral function _ NPI

  Neuropsychiatric Inventory (NPI)

  An average of 1 year

• Longitudinal functional and behavioral function _ GDS

  Geriatric Depression Scale (GDS)

  An average of 1 year

• Longitudinal functional and behavioral function _ FAQ

  Function Activities Questionnaire (FAQ)

  An average of 1 year

• Longitudinal functional and behavioral function _ ADL

  Activity of Daily Living Scale (ADL)

  An average of 1 year

• Longitudinal functional and behavioral function _ PSQI

  Pittsburgh sleep quality index (PSQI)

  An average of 1 year

• Longitudinal functional and behavioral function _ RBDSQ

  REM sleep behavior disorder screening questionnaire (RBDSQ)

  An average of 1 year

Secondary Outcomes (5)

• Longitudinal changes of plasma biomarkers

  An average of 1 year

• Longitudinal changes of CSF biomarkers

  An average of 2 years

• Longitudinal changes in neuroimaging _ MRI images

  An average of 2 years

• Longitudinal changes in neuroimaging _ amyloid PET images

  An average of 2 years

• Longitudinal changes in neuroimaging _ tau PET images

  An average of 2 years

Other Outcomes (1)

• Correlation of microbiome to Alzheimer's Disease

  1 time sampling

Interventions

Fluids biomarker and neuroimaging of AD diagnosis DIAGNOSTIC_TEST

Early diagnosis of Alzheimer's disease in South China aging population using fluids biomarker and neuroimaging.

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The GHABS cohort will recruit 1400 individuals aged 55 and older, including cognitively unimpaired older adults, subjective cognitive decline, mild cognitive impairment, and dementia.

You may qualify if:

• Age 55-90 years old (including 55 and 90 years old). However, people with autosomal dominant and other familial Alzheimer disease (FAD) are not limited by age.
• The score of the Geriatric Depression Scale (GDS) is less than 6 points.
• There is a caregiver who can maintain at least 10 hours of contact per week and can accompany volunteers to the test site for testing.
• Visual and auditory acuity is sufficient for neuropsychological testing. (Including normal corrected vision and hearing)
• Be in good health and are expected to be free of disease interference during the study.
• Volunteers are not pregnant, lactating or have reproductive potential (that is, women must be two years after menopause or undergo sterilization surgery).
• Willingness and ability to participate in longitudinal imaging studies.
• A modified version of the Hachinski Ischemic scores less than or equal to 4.
• Have completed grade 6 education or have good work experience (sufficient to rule out mental retardation).
• Must be able to speak Mandarin fluently.
• Willing to undergo multiple 3T MRI scans and at least two PET scans.
• Agree to collect blood for genomic analysis (including GWAS sequencing and other analyses), AD risk and protective genes such as apolipoprotein E (APOE), klotho, etc., and biological sample storage.
• Agree to collect blood for biomarker detection.
• Agree to share genomic data and biomarker samples.

You may not qualify if:

• MRI brain scan screening reveals infection, infarction or other focal lesions or multiple lacunes or lacunes in key memory structures.
• Any volunteers who do not meet the MRI scan requirements, including having a cardiac pacemaker, eyes, skin or metal fragments or foreign bodies in the body.
• Severe depression, bipolar affective disorder described in DSM-IV in the past year.
• Psychotic features, agitation or behavioral problems that may lead to difficulty complying with the protocol content in the past 3 months.
• Currently using medication to treat obsessive-compulsive disorder or attention deficit disorder.
• History of schizophrenia (meeting DSM-IV criteria).
• History of alcohol or drug abuse or dependence within the past 2 years (metting DSM-IV criteria).
• Any major systemic disease or unstable physical condition that may make longitudinal research difficult.
• Clinically significant abnormalities of B12 or TFTs may interfere with the study, low B12 will be excluded.
• Currently using certain psychoactive medications (e.g., certain antidepressants, neuro-depressants, chronic anxiolytics, or sedative-hypnotics). Currently using warfarin or other anticoagulants such as dabigatran, rivaroxaban, and apixaban (except lumbar puncture).
• Use of prohibited drugs.
• Simultaneously participating in other clinical studies involving neuropsychiatry.

Sponsors & Collaborators

• Shenzhen Bay Laboratory: lead
• National Natural Science Foundation of China: collaborator
• Guangdong Basic and Applied Basic Science Foundation: collaborator
• Shenzhen Science and Technology Innovation Commission: collaborator

Study Sites (1)

Shenzhen Bay Laboratory

Shenzhen, Other, 518000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebral spinal fluid, and stool

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Tengfei Guo, Ph.D.

  Shenzhen Bay Laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengyi Ge, Ph.D.

CONTACT

+8618665351340; gemy@szbl.ac.cn

Zhen Liu, Ph.D.

CONTACT

+8617685736893; liuzhen@szbl.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 27, 2023
• Study Start: May 1, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)