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Alzheimer's DiseaseGHABSNCT06183658

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

An observational study of Alzheimer's Disease, run by Shenzhen Bay Laboratory at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. The prevalence and characteristics of AD in South China's aging population 2. Read more about this study

Who is it for?
Ages 55 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
Fluids biomarker and neuroimaging of AD diagnosis
How many people
1,400 participants
Where
1 siteChina
Study dates
1 May 2021to 30 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • This project intends to recruit men and women between the ages of 55 and 90. The inclusion criteria are as listed:
  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mengyi Ge, Ph.D. contact

+8618665351340

gemy@szbl.ac.cn

Zhen Liu, Ph.D. contact

+8617685736893

liuzhen@szbl.ac.cn

China1 site, 1 recruiting

  • Shenzhen Bay Laboratory

    Shenzhen, Other, 518000

    Tengfei Guo, Ph.D., +86-0755-26849264, tengfei.guo@szbl.ac.cn

    Recruiting

Other trials in China

About this study

Official title: Greater-Bay-Area Healthy Aging Brain Study (GHABS): Biomarker- and Neuroimaging-based Study of the Pathophysiology Characterization and Evolutionary Patterns of Alzheimer's Disease

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. The prevalence and characteristics of AD in South China's aging population
  2. Identify novel biomarkers and neuroimaging techniques for early detection and intervention of AD
  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.
Read the detailed description

The Greater-Bay-Area Healthy Aging Brain Study (GHABS), a community-based longitudinal cohort study, aimed to characterize of Alzheimer's disease in South China's Aging Population, was launched in May 2021 in Shenzhen. The GHABS project was approved by the Shenzhen Bay Laboratory's and the collaborated hospitals' Ethical Committees. Each participant signed the written informed consent of the GHABS project before enrollment. The participants who met the inclusion and exclusion requirements were informed about the baseline and follow-up examinations. From 2021 to 2026, the GHABS cohort will recruit 1400 individuals aged 55 and older, including 1100 CU older adults, 200 MCI patients, and 100 dementia patients.

All the GHABS participants will undergo cognitive assessments, genetic screening, and blood sample collection. Some will have CSF collection, stool sample collection, MRI scanning, Aβ PET scanning, and tau PET scanning. All baseline examinations will be completed within three months. At follow-up, clinical assessments and blood sample collection will be conducted annually. CSF sample collection, MRI scan, Aβ PET scan, and tau PET scan are evaluated every two years.

Being tested
Fluids biomarker and neuroimaging of AD diagnosis
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluids biomarker and neuroimaging of AD diagnosisDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Longitudinal changes of cognitive function _ ADAS-Cog

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

    Measured: An average of 1 year

  2. Longitudinal changes of cognitive function _ MMSE, the Chinese version

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

    Measured: An average of 1 year

  3. Longitudinal changes of cognitive function _ MoCA-Basic

    Montreal Cognitive Assessment Basic (MoCA-Basic)

    Measured: An average of 1 year

  4. Longitudinal functional and behavioral function _ CDR

    Clinical Dementia Rating (CDR)

    Measured: An average of 1 year

  5. Longitudinal functional and behavioral function _ NPI

    Neuropsychiatric Inventory (NPI)

    Measured: An average of 1 year

  6. Longitudinal functional and behavioral function _ GDS

    Geriatric Depression Scale (GDS)

    Measured: An average of 1 year

  7. Longitudinal functional and behavioral function _ FAQ

    Function Activities Questionnaire (FAQ)

    Measured: An average of 1 year

  8. Longitudinal functional and behavioral function _ ADL

    Activity of Daily Living Scale (ADL)

    Measured: An average of 1 year

  9. Longitudinal functional and behavioral function _ PSQI

    Pittsburgh sleep quality index (PSQI)

    Measured: An average of 1 year

  10. Longitudinal functional and behavioral function _ RBDSQ

    REM sleep behavior disorder screening questionnaire (RBDSQ)

    Measured: An average of 1 year

Secondary outcomes (5)

  1. Longitudinal changes of plasma biomarkers

    Longitudinal changes of disease status as categorized by plasma biomarkers of Alzheimer's diseases over time.

    Measured: An average of 1 year

  2. Longitudinal changes of CSF biomarkers

    Longitudinal changes of disease status as categorized by CSF biomarkers of Alzheimer's diseases over time.

    Measured: An average of 2 years

  3. Longitudinal changes in neuroimaging _ MRI images

    Longitudinal change in brain structure using magnetic resonance imaging (MRI)

    Measured: An average of 2 years

  4. Longitudinal changes in neuroimaging _ amyloid PET images

    Longitudinal changes in amyloid deposition

    Measured: An average of 2 years

  5. Longitudinal changes in neuroimaging _ tau PET images

    Longitudinal changes in tau deposition

    Measured: An average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2023
  2. Study start1 May 2021
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06183658
Sponsor's protocol ID
YL2023-001
Acronym
GHABS
Status last verified
May 2025
First submitted
22 Nov 2023
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lan G, Li A, Gonzalez-Ortiz F, Lv J, Ran W, Cai Y, Sun P, Liu L, Yang J, Zhang L, He Z, Fang L, Zhou X, Zhu Y, Liu Z, Fan X, Chen X, Xu L, Wang Q, Wang X, Sun K, Cheng G, Han Y, Blennow K, Wang L, Ran P, Guo T. Higher plasma soluble TREM2 correlates with reduced cerebral tau accumulation in Alzheimer's disease. Mol Psychiatry. 2025 Sep;30(9):3988-3997. doi: 10.1038/s41380-025-02976-4. Epub 2025 Apr 1.

    PubMed 40169800

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease, run by Shenzhen Bay Laboratory at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mengyi Ge, Ph.D. (+8618665351340, gemy@szbl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Longitudinal changes of cognitive function _ ADAS-Cog (time frame: An average of 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06183658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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