Using personalized medicine to identify early cognitive impairment

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

This study is testing a new way to spot early signs of cognitive impairment in people aged 55-70 by using different types of information and advanced technology.

Quick facts

• Study type: Observational
• Enrollment: 1150 (estimated)
• Ages: 55 Years to 70 Years
• Sex: All
• Sponsor: Instituto de Salud Carlos III (other gov)
• Locations: 8 sites (San Vicente Del Raspeig, Alicante and 7 other locations)
• Trial ID: NCT06114290 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop predictive models for the early detection of cognitive impairment (CI) in individuals aged 55-70 by integrating various data types, including clinical, molecular, and behavioral information. Utilizing advanced artificial intelligence techniques, the study will analyze data collected from participants across six regions in Spain, focusing on those without an established diagnosis of CI. The research will employ a mixed methods approach, combining quantitative and qualitative data to enhance understanding and prediction of cognitive dysfunction.

Who should consider this trial

Good fit: Ideal candidates for this study are non-institutionalized individuals aged 55-70 years who have a recorded health history in the past year and do not have an established diagnosis of cognitive impairment.

Not a fit: Patients who are hospitalized, institutionalized, or have significant difficulties completing self-reported questionnaires may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and intervention for cognitive impairment, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using integrated data and AI for early detection of cognitive impairment, suggesting a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

San Vicente Del Raspeig, Alicante and 7 other locations

• Sant Vicent I Health Center — San Vicente Del Raspeig, Alicante, Spain (RECRUITING)
• Camps Blanc Health Center — Sant Boi De Llobregat, Barcelona, Spain (RECRUITING)
• Zone 8 Health Center — Albacete, Castilla-La Mancha, Spain (RECRUITING)
• Gibraleón Health Center — Gibraleón, Huelva, Spain (RECRUITING)
• Punta Umbría Health Center — Punta Umbría, Huelva, Spain (RECRUITING)
• Irala Health Center — Bilbao, Spain (RECRUITING)
• Onze de Setembre Health Center — Lleida, Spain (RECRUITING)
• San Andres Health Centre — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Angeles Almeida, PhD — Consejo Superior de Investigaciones Científicas (CSIC)
• Study coordinator: Mayte Moreno-Casbas

Conditions: Cognitive Dysfunction, Early Diagnosis, Primary Health Care, Biomarkers, Artificial Intelligence, Precision Medicine, Care