Mild Cognitive Impairment and Psychopathology

NCT07358962 | Not Yet Recruiting

• 1 other identifier: 11/2025
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment (MCI); Psychopathological disorders; Anosognosia; Cognitive decline; Social functioning; Work functioning; Neuropsychological assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

MCI

Patients diagnosed with Mild Cognitive Impairment

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Me, 98124, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Agnosia; Social Adjustment

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Central Study Contacts

Irene Cappadona

CONTACT

+393274409990; irene.cappadona@irccsme.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PSYCHOLOGIST

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)