TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. A Biopsychosocial Model for the Early and Accurate Diagnosis of the Alzheimer's Disease Continuum.
TRIAD Study: Improving Alzheimer's Diagnosis with a Holistic Approach
Plain English Summary
TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. is a Not Applicable clinical trial sponsored by Istituti Clinici Scientifici Maugeri SpA studying Cognitive Decline. This study tests a new way to diagnose Alzheimer's disease by looking at biological, psychological, and social factors together. It's for individuals aged 50 and older experiencing cognitive decline and their primary caregivers. Participation involves assessments of memory, thinking, and well-being for both patients and caregivers. Currently, Alzheimer's diagnosis often relies on separate assessments; this trial aims to integrate these for a more complete picture. The trial aims to enroll 80 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 50 or older with cognitive decline can join if they have a caregiver who can also participate. Individuals with a history of other brain disorders, severe mental health issues, or certain medical conditions may not be eligible. Caregivers must be at least 18 years old, have been providing care for at least six months, and be able to participate in study assessments. This trial is studying Cognitive Decline, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure cognitive function using standard tests to see how well the integrated approach identifies different stages of Alzheimer's. The specific primary outcome measures are: Mini Mental State Examination (MMSE) (Baseline); Montreal Cognitive Assessment (MoCA) (Baseline); Mental Deterioration Battery (MDB) (Baseline); Free and Cue Selective Reminding Test (FCSRT) (Baseline); Frontal Assessment Battery (FAB) (Baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve the early and accurate diagnosis of Alzheimer's disease by considering a wider range of factors beyond just biological markers. This research targets Cognitive Decline, where improved treatment options are needed.
Investor Insight
This observational study focuses on diagnostic improvement, suggesting potential for future diagnostic tools and services in the growing Alzheimer's market.
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the assessments will involve. Be prepared for regular visits for cognitive tests, interviews, and possibly other assessments for both you and your caregiver. Your caregiver's involvement is crucial, as their experiences and well-being are also being studied. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 80 participants
Primary Outcomes
- Mini Mental State Examination (MMSE) (Baseline)
- Montreal Cognitive Assessment (MoCA) (Baseline)
- Mental Deterioration Battery (MDB) (Baseline)
- Free and Cue Selective Reminding Test (FCSRT) (Baseline)
- Frontal Assessment Battery (FAB) (Baseline)
Full 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.
Trial Locations
- ICS Maugeri Montescano Institute, Montescano, Pavia, Italy, Italy
Frequently Asked Questions
What is clinical trial NCT07399418?
NCT07399418 is a Not Applicable OBSERVATIONAL study titled "TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.." It is currently recruiting and is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial targets enrollment of 80 participants.
What conditions does NCT07399418 study?
This trial investigates treatments for Cognitive Decline. The primary condition under study is Cognitive Decline.
What does Not Applicable mean for NCT07399418?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07399418?
This trial is currently "Recruiting." It started on 2025-09-01. The estimated completion date is 2027-12-31.
Who is sponsoring NCT07399418?
NCT07399418 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07399418?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT07399418 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07399418?
The primary outcome measures are: Mini Mental State Examination (MMSE) (Baseline); Montreal Cognitive Assessment (MoCA) (Baseline); Mental Deterioration Battery (MDB) (Baseline); Free and Cue Selective Reminding Test (FCSRT) (Baseline); Frontal Assessment Battery (FAB) (Baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07399418 being conducted?
This trial is being conducted at 1 site, including Montescano, Pavia, Italy (Italy).
Where can I find official information about NCT07399418?
The official record for NCT07399418 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07399418. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07399418 testing in simple terms?
This study tests a new way to diagnose Alzheimer's disease by looking at biological, psychological, and social factors together. It's for individuals aged 50 and older experiencing cognitive decline and their primary caregivers.
Why is this trial significant?
This trial matters because it aims to improve the early and accurate diagnosis of Alzheimer's disease by considering a wider range of factors beyond just biological markers.
What are the potential risks of participating in NCT07399418?
Potential risks include fatigue or emotional distress from cognitive testing and interviews. Side effects are generally minimal for this type of observational study, but may include temporary discomfort during assessments. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07399418?
Ask your doctor if this study is right for you and what the assessments will involve. Be prepared for regular visits for cognitive tests, interviews, and possibly other assessments for both you and your caregiver. Your caregiver's involvement is crucial, as their experiences and well-being are also being studied. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07399418 signal from an investment perspective?
This observational study focuses on diagnostic improvement, suggesting potential for future diagnostic tools and services in the growing Alzheimer's market. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves assessments of memory, thinking, and well-being for both patients and caregivers. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.