TRIADMultidimensional Clinical Profiles for Early Alzheimer's Disease Detection: Biological, Psychological and Social Factors
This observational study aims to create multidimensional clinical profiles for early detection of Alzheimer's disease by evaluating biological, psychological, and social factors in participants.
Data Collection
Collected from today forward - ProspectiveAlzheimer Disease+11
+ Mental Disorders
+ Brain Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.The TRIAD study aims to improve the early detection and understanding of Alzheimer's disease (AD). It combines blood-based biomarkers, neuro-imaging, neuro-psychology, and psychosocial factors, including the experiences of caregivers, to create a comprehensive view of the disease. The study aims to fill gaps in current knowledge, such as the lack of non-invasive tools for early detection and the limited understanding of how caregivers cope with AD in its various stages. The primary objectives include analyzing biological, psychological, and social factors at different stages of AD, examining the influence of these factors on the quality of life of patients and caregivers, and investigating the relationship between caregiver psychological well-being and patient cognitive functioning. Patients will undergo an initial clinical and neurological evaluation, followed by routine blood tests and structural neuroimaging investigations. When clinically indicated, amyloid positron emission tomography (PET) will also be performed. Patients will then complete a standardized neuropsychological test battery. Based on these results, each patient will be assigned to one of four diagnostic groups along the Alzheimer's disease continuum. After assignment to the clinical stage, patients will undergo the assessment of plasma biomarkers of neurodegeneration and neuroinflammation. In addition, patients will complete a series of self-report questionnaires assessing emotional symptoms, perceived stress, quality of life, and cognitive reserve. Concurrently, caregivers will be asked to complete selected self-report questionnaires evaluating caregiver burden, emotional symptoms, coping strategies, metacognitive beliefs, and quality of life.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
ICS Maugeri Montescano Institute
Montescano, ItalyOpen ICS Maugeri Montescano Institute in Google Maps