Mild Cognitive Impairment and Psychopathology

ConditionMild Cognitive Impairment (MCI)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50-72

SponsorIRCCS Centro Neurolesi Bonino Pulejo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

As this is a cross-sectional observational study involving a single group of MCI patients, the sample size was estimated a priori using G\*Power 3.1 with a one-sample binomial test (two-tailed) for the primary objective, namely the estimation of the prevalence of psychopathological disorders. In accordance with the literature, an expected prevalence of p1 = 0.20 was assumed and compared with a reference value of p2 = 0.32 (α = 0.05; power 1-β = 0.85), yielding an estimated sample size of N = 118 subjects. Considering a 15% margin for potential drop-outs or invalid data, the final sample size was set at N = 136 participants.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

118 Participants

are grouped into 1 trial group

Group A: MCI

Trial outcomes

Primary outcomes

Prevalence of psychopathological disorders in patients with MCI

The primary outcome variable is the presence of psychopathological disorders, assessed using the MMPI-3 test, which is used as an indicator of the psychopathological profile in patients with mild cognitive impairment.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Centro Neurolesi Bonino Pulejo

Lead sponsor

Source ClinicalTrials.gov

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