Actively Recruiting
TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-02-17
80
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
I
Istituti Clinici Scientifici Maugeri SpA
Lead Sponsor
C
Catholic University of the Sacred Heart
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 50 years or older
- Presence of a primary caregiver who can actively participate in the study
- Ability to understand the research and provide informed consent
- Caregivers aged 18 years or older
- Caregivers who have been primary caregivers for at least six months
- Caregivers able to understand the research and provide informed consent
You will not qualify if you...
- Patients under 50 years of age
- History of neurological disorders affecting cognitive function such as severe strokes, brain tumors, or traumatic injuries
- History of major psychiatric disorders including schizophrenia, severe bipolar disorder, or untreated major depression
- Alcohol or substance abuse
- Medical conditions that may affect cognitive function, including advanced kidney or liver failure, severe respiratory disorders, untreated hypothyroidism, or B12 deficiency
- Unstable systemic diseases with significant organ failure
- Severe sensory impairments (hearing or vision) or language difficulties
- Participation in clinical trials of anti-amyloid or experimental AD drugs within the last 6 months
- Caregivers with severe active psychiatric disorders such as untreated major depression or psychotic disorders
- Caregivers unable to participate in interviews and assessments due to language, cognitive, or personal limitations
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ICS Maugeri Montescano Institute
Montescano, Pavia, Italy, Italy, 27040
Actively Recruiting
Research Team
C
Cira Fundarò, Neurologist
CONTACT
M
Marina Maffoni, Psychologist
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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