Combining biological, psychological and social factors to diagnose Alzheimer's disease earlier
Observes people with cognitive decline and their caregivers across stages of Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.
Key facts
- Where
- Montescano, ItalySee the site
Where in Italy
- ICS Maugeri Montescano InstituteMontescano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Trial code
- NCT07399418
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. A Biopsychosocial Model for the Early and Accurate Diagnosis of the Alzheimer's Disease Continuum.
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.
Inclusion: 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.
Exclusion: History of previous or concomitant neurological disorders (e.g., severe cerebrovascular accidents, brain tumors, traumatic injuries affecting cognitive functions) and neurodegenerative disorders; 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; 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; Presence of severe active psychiatric disorders (e.g., untreated major depression, psychotic disorder, or schizophrenia); Age under 50; Marked sensory limitations (hearing or vision) and/or language difficulties; Difficulty participating in interviews and assessments due to language barriers, cognitive deficits, or other personal limitations.