Not Yet RecruitingNot Applicable

Mild Cognitive Impairment and Psychopathology

Italy118 participantsStarted 2026-01-12

Plain-language summary

Mild Cognitive Impairment (MCI) is a condition characterized by cognitive deterioration greater than what is expected from normal aging, representing an important risk factor for the development of dementia. Early assessment of cognitive functions is therefore essential for promptly identifying any signs of decline. In addition to cognitive aspects, it is equally important to consider the possible psychopathological profile of patients, as such disorders can significantly influence the progression of the disease, quality of life, and the ability to manage daily activities. This protocol aims to explore the presence of psychopathological disorders in patients with MCI, with particular attention to their impact on awareness of cognitive deficits (anosognosia) and on the subjective perception of difficulties in daily life, especially in social and work contexts. The study seeks to outline a comprehensive picture of the psychopathological profile in patients with MCI, facilitating the identification of targeted and personalized interventions capable of improving clinical management and the overall well-being of the individual.

Who can participate

Age range

50 Years – 72 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 50 and 72 years; * Diagnosis of Mild Cognitive Impairment (MCI), with referral to the Neuropsychology clinic for an initial evaluation or for clinical monitoring; * Absence of behavioral, psychiatric, or sensory disorders that could significantly compromise the performance of cognitive tests or the completion of questionnaires. Exclusion Criteria: * Neurological disorders other than MCI, such as recent stroke, severe traumatic brain injury, epilepsy, multiple sclerosis, or other atypical neurodegenerative diseases; * Major psychiatric comorbidities not stabilized at the time of the assessment (e.g., schizophrenia, bipolar disorder in an active phase, untreated severe depression); * Severe uncorrected sensory deficits (visual or hearing) capable of compromising the validity of cognitive and functional assessments; * Use of medications with significant potential cognitive impact (e.g., sedatives, high-dose antipsychotics) not stabilized at the time of the assessment; * Terminal-stage internal or oncological diseases, or other medical conditions that significantly interfere with the assessment procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of psychopathological disorders in patients with MCI

Timeframe: 12 months

Trial details

NCT IDNCT07358962

SponsorIRCCS Centro Neurolesi Bonino Pulejo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01-12

Contact for this trial

Irene Cappadona

+393274409990 irene.cappadona@irccsme.it

View on ClinicalTrials.gov More Mild Cognitive Impairment (MCI) trials