Identifying biomarkers for early diagnosis of Alzheimer's disease

Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease

This study is trying to find early signs of Alzheimer's disease by looking at a large group of older people in China to help diagnose and treat the condition sooner.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04575337 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a large population-based cohort of elderly individuals in China, including those with Alzheimer's disease (AD), mild cognitive impairment (MCI), and normal cognitive function. It will collect clinical, cognitive, genetic, neuroimaging, and biospecimen data to identify specific biomarkers associated with different stages of AD. The study will also develop risk prediction models to forecast the onset and progression of AD over a five-year follow-up period. By employing standardized assessment protocols, the project seeks to enhance early diagnosis and intervention strategies for Alzheimer's disease.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly individuals aged 18 and older, including those diagnosed with Alzheimer's disease, mild cognitive impairment, or those with normal cognitive function.

Not a fit: Patients under the age of 18 or those with significant medical or psychiatric illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of Alzheimer's disease, allowing for timely interventions.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for Alzheimer's disease, but this approach focuses on a comprehensive population-based cohort, making it a novel effort.

Eligibility criteria

Inclusion Criteria:

* Written informed consent obtained from participant or legal guardian prior to any study-related procedures.
* Aged 18 (inclusive) or older.
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales.
* Follow up 5 years and collect the information.

Exclusion Criteria:

* Under age 18.
* Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
* No one can serve as a study informant.
* With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
* Refused to complete a cognitive test and provide biospecimen.
* With history of alcohol or drug abuse.

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital of Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jianping Jia, Doctor

Conditions Alzheimer Disease