Integrated tracking of Alzheimer's risk using biological, psychological, and caregiver data

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ICS Maugeri Montescano Institute
  Montescano, Pavia, Italy, Italy Recruiting

Study contacts

• Study coordinator: Cira Fundarò, Neurologist
• Email: cira.fundaro@icsmaugeri.it
• Phone: +39 0385247268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.