Integrated tracking of Alzheimer's risk using biological, psychological, and caregiver data
TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. A Biopsychosocial Model for the Early and Accurate Diagnosis of the Alzheimer's Disease Continuum.
We will test whether combining blood markers, brain imaging, cognitive testing, and caregiver-reported information can better identify early Alzheimer's stages in people aged 50 and older who have a primary caregiver.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Montescano, Pavia, Italy) |
| Trial ID | NCT07399418 on ClinicalTrials.gov |
What this trial studies
This observational project follows people along the Alzheimer's continuum to build multidimensional clinical profiles by combining blood-based biomarkers, neuroimaging, neuropsychological testing, and psychosocial measures including caregiver experience. Investigators will use these data to create integrated risk models that map biological, psychological, and social contributors at different disease stages. The protocol enrolls patients aged 50+ together with their primary caregivers and collects clinical, cognitive, biomarker, and caregiver well-being data. Results aim to clarify how caregiver psychological status relates to patient cognition and quality of life across early and later stages.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older experiencing cognitive decline who have a willing primary caregiver and can provide informed consent.
Not a fit: People under 50, those without a primary caregiver, or those with major confounding neurological or psychiatric conditions are unlikely to receive direct benefit from the study's findings.
Why it matters
Potential benefit: If successful, this approach could enable earlier, less invasive detection and more personalized care planning for people on the Alzheimer's continuum.
How similar studies have performed: Previous work has shown promise for blood biomarkers and for psychosocial caregiver measures separately, but combining biological, imaging, and caregiver-reported data into integrated risk models is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (patients): * 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. Inclusion Criteria (caregivers): * 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. Exclusion Criteria (patients): * Age under 50. * History of previous or concomitant neurological disorders (e.g., severe cerebrovascular accidents, brain tumors, traumatic injuries affecting cognitive functions) and neurodegenerative disorders. * History of major psychiatric disorders (e.g., schizophrenia, severe bipolar disorder, untreated major depression), alcohol or substance abuse. * Medical conditions that may interfere with cognitive function (e.g., advanced renal or hepatic failure, severe respiratory disorders, untreated hypothyroidism, B12 deficiency). * Decompensated systemic diseases with clinical instability and significant organ failure. * Marked sensory limitations (hearing or vision) and/or language difficulties. * Participation in other experimental studies involving previous or current involvement in clinical trials of anti-amyloid drugs or experimental drug treatments for AD in the previous 6 months. Exclusion Criteria (caregivers): * Presence of severe active psychiatric disorders (e.g., untreated major depression, psychotic disorder, or schizophrenia). * Difficulty participating in interviews and assessments due to language barriers, cognitive deficits, or other personal limitations.
Where this trial is running
Montescano, Pavia, Italy
- ICS Maugeri Montescano Institute — Montescano, Pavia, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Cira Fundarò, Neurologist
- Email: cira.fundaro@icsmaugeri.it
- Phone: +39 0385247268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.