Personalised Medicine in the Identification of Preclinical Cognitive Impairment. Development of a Predictive Risk Model

NCT06114290 | Unknown

• 1 other identifier: PMP22/00084
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this observational study is to use the combined power of the integration of clinical, molecular, proteomic, genomic, care, social, environmental and behavioural data in patients, using advanced artificial intelligence techniques for data processing and analysis, in order to generate predictive models for the preclinical detection of CI in the population aged 55-70 years.

Conditions

Cognitive Dysfunction

Keywords

Cognitive Dysfunction; Early Diagnosis; Primary Health Care; Biomarkers; Artificial Intelligence; Precision Medicine; Care

Outcome Measures

Primary Outcomes (1)

• Cognitive level

  Evaluated with Minimental State Examination (min 0 - max 30, higher scores mean a better outcome) and Montreal Cognitive Assessment (min 0 - max 30, higher scores mean a better outcome)

  16 months

Secondary Outcomes (6)

• multi-omics biomarkers

  16 months

• Social support network.

  16 months

• social interactions

  16 months

• personalised behavioural patterns.

  16 months

• Gait speed

  16 months

Eligibility Criteria

• Age: 55 Years - 70 Years
• Gender Eligibility Details: Understanding how factors interrelate with sex or gender will be important in determining user needs and in explaining or predicting differences in outcomes. Where differences in levels of participation and/or acceptance of participation in the project between men and women are identified, these will be explained and measures identified to address them.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be carried out on non-institutionalised subjects in the study locations, aged 55 to 70 years, attached to the PC centres of the territories included in the study, with a living history (at least one record in the last 12 months). The individuals will be selected from lists of patients from the participating practices in the 7 geographical locations, each of them providing 150 patients. The sample will be obtained by stratified by age (5-year wide strata) and sex who do not include any diagnosis of mild CD in their clinical records (MMSE= 24-27 points). Any refusal to participate after screening will be replaced by the next subject on the sampling list from the same centre and stratum. Samples will be collected at baseline and at 16 months.

You may qualify if:

• Non-institutionalised subjects from the study locations.
• Aged between 55 and 70 years, attached to the PC centres of the territories included in the study
• Living history (at least one record in the last 12 months)
• Without an established diagnosis of CI.

You may not qualify if:

• Participants with significant difficulties in completing self-reported questionnaires
• Those in whom genetic or biological testing may be affected by an underlying genetic or health condition.
• Underlying genetic or health condition.
• Patients who are hospitalised or institutionalised during follow-up will be excluded.

Sponsors & Collaborators

• Instituto de Salud Carlos III: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Carlos III Health Institute: collaborator
• Universidad Complutense de Madrid: collaborator
• Biomedical Research Networking Centre on Frailty and Healthy Ageing: collaborator
• Biomedical Research Networking Centre on Mental Health: collaborator
• Institute of Biomedical Research of Lleida: collaborator
• Institute of Health and Biomedical Research of Alicante: collaborator
• Carlos III University of Madrid: collaborator
• University of Vigo: collaborator
• Foundation for Biosanitary Research and Innovation in Primary Health Care: collaborator
• Biomedical Research Networking Centre on Epidemiology and Public Health: collaborator
• Research Network on Chronicity, Primary Care and Health Prevention and Promotion: collaborator

Study Sites (8)

Sant Vicent I Health Center

San Vicent del Raspeig, Alicante, 03690, Spain

RECRUITING

Camps Blanc Health Center

Sant Boi de Llobregat, Barcelona, 08830, Spain

RECRUITING

Zone 8 Health Center

Albacete, Castille-La Mancha, 02006, Spain

RECRUITING

Gibraleón Health Center

Gibraleón, Huelva, 21500, Spain

RECRUITING

Punta Umbría Health Center

Punta Umbría, Huelva, 21100, Spain

RECRUITING

Irala Health Center

Bilbao, 48012, Spain

RECRUITING

Onze de Setembre Health Center

Lleida, 25005, Spain

RECRUITING

San Andres Health Centre

Madrid, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples to be retained are peripheral blood mononuclear cells (PBMCs), and plasma from all patients at two different time points (basal and after 18 months from the first blood collection)

MeSH Terms

Conditions

Cognitive Dysfunction; Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angeles Almeida, PhD

  Consejo Superior de Investigaciones Científicas (CSIC)

  PRINCIPAL INVESTIGATOR

• Rodrigo Barderas, PhD

  Instituto de Salud Carlos III

  PRINCIPAL INVESTIGATOR

• MARIA TERESA MORENO-CASBAS, PhD

  Nursing and Healthcare Research Unit (Investén-isciii). Instituto de Salud Carlos III. Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayte Moreno-Casbas

CONTACT

+34 637390052; mmoreno@isciii.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of National Healthcare Research Unit Investén-isciii

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: During 2026
• Access Criteria: They will be published on the Rapisalud platform (https://repisalud.isciii.es).

Locations

ES (8)