RecruitingNCT07399418

TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.

TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. A Biopsychosocial Model for the Early and Accurate Diagnosis of the Alzheimer's Disease Continuum.


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

80 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The study is based on the hypothesis that the integration of biological, psychological, and social factors, according to the biopsychosocial paradigm, allows for more accurate identification of the different stages of the Alzheimer's continuum (AD), facilitating early diagnosis and effective management. It is also hypothesized that the experience of the caregiver is a key element, capable of influencing the patient's experience and clinical course, representing a potential early indicator of risk. Primary objectives are (PO.1) Jointly analyze biological, psychological, and social factors at different stages of the AD continuum to construct multidimensional clinical profiles and integrated risk models. (PO.2) Examine the influence of psychological and social variables on the quality of life of patients and caregivers at different stages of the disease. (PO.3) Investigate the relationship between caregiver psychological well-being and patient cognitive functioning, exploring potentially bidirectional relationships. Secondary objectives are (SO.1) Compare biomarkers and neuropsychological performance at different stages of the AD clinical continuum. (SO.2) Evaluate the diagnostic effectiveness of blood and neuroimaging biomarkers in discriminating the severity of cognitive impairment. (SO.3) Explore stress and coping strategies adopted by caregivers, in relation to the stage of the disease and the quality of the dyadic relationship. (So.4) Integrate quantitative and qualitative data to understand the emotional experience of the caregiver throughout the entire disease continuum.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients aged 50 and older who are being evaluated for Alzheimer's disease or memory concerns, tracking their diagnosis, symptoms, caregiver experience, and quality of life over time. The goal is to better understand how integrated diagnostic approaches — combining clinical, biological, and imaging markers — affect care decisions and outcomes. **You may be eligible if (as a patient)...** - You are 50 or older - You have a primary caregiver who can actively participate - You can understand the study and give informed consent **You may be eligible if (as a caregiver)...** - You are 18 or older - You have been providing regular care for the patient for at least 6 months **You may NOT be eligible if...** - You do not have a primary caregiver available to participate - You are unable to understand the study objectives or give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

ICS Maugeri Montescano Institute

Montescano, Pavia, Italy, Italy

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NCT07399418


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