TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.
Recruiting · NCT07399418 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
View the official record on ClinicalTrials.gov →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.
Who can take part
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 is running
1 location listed.
- ICS Maugeri Montescano Institute - Montescano, Pavia, Italy, Italy