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TRIADMultidimensional Clinical Profiles for Early Alzheimer's Disease Detection: Biological, Psychological and Social Factors

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Study Aim

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.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Alzheimer Disease+11

+ Mental Disorders

+ Brain Diseases

Over 50 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: September 2025
See protocol details

Summary

Principal SponsorIstituti Clinici Scientifici Maugeri SpA
Study ContactCira Fundarò, NeurologistMore contacts
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. A Biopsychosocial Model for the Early and Accurate Diagnosis of the Alzheimer's Disease Continuum.
Principal SponsorIstituti Clinici Scientifici Maugeri SpA
Study ContactCira Fundarò, NeurologistMore contacts
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaDiseaseNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

6 inclusion criteria required to participate
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.

Age ≥ 50 years.

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9 exclusion criteria prevent from participating
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.

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Recruiting

ICS Maugeri Montescano Institute

Montescano, ItalyOpen ICS Maugeri Montescano Institute in Google Maps
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One Study Center