Observational study on Alzheimer's disease in older adults in South China

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

This study is trying to understand how common Alzheimer's disease is among older adults in South China and see if certain tests can help spot it early.

Quick facts

• Study type: Observational
• Enrollment: 1400 (estimated)
• Ages: 55 Years to 90 Years
• Sex: All
• Sponsor: Shenzhen Bay Laboratory (other)
• Locations: 1 site (Shenzhen, Other)
• Trial ID: NCT06183658 on ClinicalTrials.gov

What this trial studies

The Greater-Bay-Area Healthy Aging Brain Study (GHABS) aims to investigate the characteristics and prevalence of Alzheimer's disease among older adults in South China. This observational study will recruit 1400 participants aged 55 and older, including cognitively unimpaired individuals, those with mild cognitive impairment, and dementia patients. Participants will undergo various assessments, including cognitive tests, blood sample collection, and advanced neuroimaging techniques to identify novel biomarkers for early detection and intervention of Alzheimer's disease. The study will follow participants over several years to track changes and gather comprehensive data on the disease's evolution.

Who should consider this trial

Good fit: Ideal candidates for this study are men and women aged 55 to 90 who are in good health and can participate in longitudinal assessments.

Not a fit: Patients with autosomal dominant and other familial Alzheimer's disease may not benefit from this study as they are not the primary focus.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and intervention strategies for Alzheimer's disease, potentially enhancing patient outcomes.

How similar studies have performed: Other studies have shown success in using neuroimaging and biomarker identification for Alzheimer's disease, indicating that this approach has potential.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Shenzhen, Other

• Shenzhen Bay Laboratory — Shenzhen, Other, China (RECRUITING)

Study contacts

• Principal investigator: Tengfei Guo, Ph.D. — Shenzhen Bay Laboratory
• Study coordinator: Mengyi Ge, Ph.D.

Conditions: Alzheimer's Disease