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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Age ≥ 50 years.

• Presence of a primary caregiver, i.e., a person who provides regular care and who can actively participate in the study.

• Understanding of the research objectives and ability to provide informed consent.

• Be the primary caregiver, providing care for at least six months.

• Age ≥ 18 years, to ensure the ability to understand and actively participate in the study.

• Understanding of the research objectives and ability to provide informed consent.

Locations
Other Locations
Italy
ICS Maugeri Montescano Institute
RECRUITING
Montescano
Contact Information
Primary
Cira Fundarò, Neurologist
cira.fundaro@icsmaugeri.it
+39 0385247268
Backup
Marina Maffoni, Psychologist
marina.maffoni@icsmaugeri.it
+39 0385247212
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 80
Related Therapeutic Areas
Sponsors
Collaborators: Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov