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临床试验/NCT07521722
NCT07521722尚未招募不适用

DIV-AD BARCELONA: Alzheimer's Blood-Based Biomakers for a Diverse Community

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
Plasma levels of Alzheimer's disease blood-based biomarkers across ethnic groups

研究概览

简要总结

The DIV-AD study aims to find out whether levels of Alzheimer's disease markers in blood differ among the main ethnical groups living in central Barcelona.

It will also examine how factors such as age, income, education, and health conditions may affect these levels.

In addition, the study will identify barriers that may make it difficult to use these blood tests in primary care.

The final goal is to help ensure that everyone in Barcelona has fair access to early prevention strategies for Alzheimer's disease.

详细描述

Background and Rationale Alzheimer's disease (AD) is the leading cause of dementia worldwide and represents a major public health challenge. Blood-based biomarkers (BBBs) for AD - including phosphorylated tau isoforms (p-tau181, p-tau217, p-tau231), amyloid-beta peptides (Aβ40, Aβ42), brain-derived tau (BD-tau), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL) - have emerged as accessible, scalable, and minimally invasive tools for the early and accurate detection of AD pathology. These biomarkers are increasingly being integrated into research studies, clinical trials, and prevention programs. Their accessibility makes them particularly promising for community-level screening and recruitment into prevention studies.

However, the vast majority of research on BBBs has been conducted in highly educated, non-Hispanic White (NHW) populations from the United States and Europe. Ethnic minorities and migrant communities remain substantially underrepresented in this body of literature, raising serious concerns about the generalizability and equity of current biomarker thresholds, reference ranges, and clinical applications. A growing number of studies suggest that BBB levels may differ across ethnic groups, potentially due to disparities in demographic, socioeconomic, lifestyle, and biological factors. Without a clear understanding of these differences, the implementation of BBBs in routine clinical care risks perpetuating or even widening existing health disparities.

Spain, and Barcelona in particular, occupies a leading position in the development and validation of BBBs. Yet, to date, no study has systematically examined the performance of BBBs in a diverse, multi-ethnic cohort within the Spanish or European context. The Primary Care Team Raval Sud (EAP Raval Sud) in Barcelona provides a unique real-world setting to address this gap: it serves a highly diverse population, with over 60% of its approximately 32,000 registered patients being foreign-born, representing a broad spectrum of ethnic backgrounds including South Asian (Pakistani, Indian, Bangladeshi), Filipino, Latin American, and Maghrebi communities.

Study Overview The DIV-AD BARCELONA study is a prospective, observational, cross-sectional investigation that will enroll 250 cognitively unimpaired (CU) adults aged 50-75 years from five self-identified ethnic groups, recruited at EAP Raval Sud. The study pursues two overarching goals: (1) to characterize and compare BBB levels across diverse ethnic groups and identify the demographic, socioeconomic, medical, and biological determinants of any observed differences; and (2) to assess the frequency of biomarker-defined AD pathology across these groups, validate a cross-cultural cognitive screening tool (RUDAS), evaluate dementia knowledge and stigma, and develop culturally tailored educational and healthcare interventions to promote equitable access to AD prevention.

Study Procedures

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cognitively Unimpaired individuals aged between 50 and 75 years at the time of signing the informed consent
  • Individuals interested in participating, able to follow study procedures, and who understand that all the tests are carried out in a research context.
  • Explicit desire to participate in the tests and procedures of the study, including: collection of study variables, cognitive and neurologic assessment, blood sampling.
  • Signing the informed consent, agreeing not to receive the research results that will not be of no clinical interest for the participant.

排除标准

  • Cognitive decline defined by CDR>
  • Individuals with cognitive complaints and who have sought for medical help for cognitive impairment at any time in their life
  • Patients with relevant medical illnesses that may significantly interfere with the interpretation of results. This includes auditory and visual perception disorders, active oncological disease under treatment (localized tumors are excluded) and any condition that, in the investigator's opinion, may interfere with the correct performance/interpretation of the study procedures and/or with future permanence in the study.
  • Major psychiatric disorders (according to the DSM-V manual) or diseases that affect cognitive abilities (major depressive episode, bipolar disorder, schizophrenia, etc).
  • Acquired brain damage: history of head trauma with macroscopic parenchymal or non-axial lesion, large-vessel ischemic or hemorrhagic stroke, brain tumours and any other etiologies that can cause acquired brain damage (i.e., chemotherapy or brain radiotherapy).
  • Parkinson's disease, epilepsy under treatment and with frequent seizures (> 1/month) in the last year, multiple sclerosis or other neurodegenerative diseases.

研究组 & 干预措施

Maghrebi

50 participants from any country of the Magheb region (Morocco, Tunisia, Mauritania, Algeria, Libya)

European

50 participants from any European country

South Asian

50 participants from Pakistan, India, Bangladesh

Filipinos

50 participants from Philippines

Latin America

50 participants from any country of South America

结局指标

主要结局

Plasma levels of Alzheimer's disease blood-based biomarkers across ethnic groups

时间窗: Through study completion, an average of 1 year

The contribution of sociodemographic factors, medical comorbidities, and biological variables to observed differences in levels of blood-based biomarkers will be assessed.

次要结局

  • Proportion of participants classified as low, intermediate, or high risk for AD pathology by plasma p-tau217 threshold, per ethnic group(Through study completion, an average of 1 year)

研究者

发起方
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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