NCT07521722

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2027

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

March 30, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Alzheimer's diseaseADBlood-based biomarkersPlasma biomarkersPhosphorylated tauAmyloid betaNeurofilament light chainGFAPEthnic diversityHealth disparitiesCognitively unimpairedPreclinical Alzheimer's diseasePrimary careDementia preventionCross-cultural cognitive assessmentRUDASDementia knowledgeDementia stigmaGenetic ancestryMigrant populationsHealth equityDiversity

Outcome Measures

Primary Outcomes (1)

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

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

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • 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

Other Outcomes (2)

  • Validation of the RUDAS scale in a multi-ethnic primary care population

    Single time-point assessment (cross-sectional)

  • Coded thematic categories from in-depth interviews on healthcare barriers, dementia stigma, and illness narratives

    Year 1

Study Arms (5)

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

Maghrebi

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

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will enroll 250 cognitively unimpaired adults aged 50-75 years, recruited from the patient registry of the Primary Care Team Raval Sud (EAP Raval Sud) in Barcelona, Spain. This primary care center is embedded in the Raval neighborhood of the Ciutat Vella district, one of the most ethnically diverse areas of Barcelona, characterized by a high proportion of foreign-born residents (over 63%)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive decline defined by CDR\>0.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BarcelonaBeta Brain Research Center - EAP Raval Sud

Barcelona, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for the analysis of Alzheimer's disease biomarkers Blood samples for the extraction and analysis of DNA

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementiaNeurodegenerative DiseasesPlaque, AmyloidCharcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental DisordersCognition DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 13, 2026

Study Start (Estimated)

April 27, 2026

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

January 1, 2029

Last Updated

April 13, 2026

Record last verified: 2026-02

Locations