NCT07399418 TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.
| NCT ID | NCT07399418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Cognitive Decline |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-09-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07399418 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07399418 currently recruiting?
Yes, NCT07399418 is actively recruiting participants. Contact the research team at cira.fundaro@icsmaugeri.it for enrollment information.
Where is the NCT07399418 trial being conducted?
This trial is being conducted at Montescano, Italy.
Who is sponsoring the NCT07399418 clinical trial?
NCT07399418 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 80 participants.