NCT06183658Recruiting
Greater-Bay-Area Healthy Aging Brain Study (GHABS)
Greater-Bay-Area Healthy Aging Brain Study (GHABS): Biomarker- and Neuroimaging-based Study of the Pathophysiology Characterization and Evolutionary Patterns of Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 22 Nov 2023
- Start date
- 1 May 2021
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Shenzhen Bay Laboratory
- Diseases
- Alzheimer disease
- NCT number
- NCT06183658
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 1 May 2021 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently using medication to treat obsessive-compulsive disorder or attention deficit disorder.
- 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.
Other illness
- 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.
- 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.
Other
- Psychotic features, agitation or behavioral problems that may lead to difficulty complying with the protocol content in the past 3 months.
- Clinically significant abnormalities of B12 or TFTs may interfere with the study, low B12 will be excluded.
- Simultaneously participating in other clinical studies involving neuropsychiatry.
Who the study is looking for
- 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.
- 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.
Age in the registry: 55 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Bay Laboratory Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.