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Mind and memory: new study links mental health to social and work struggles in MCI

NCT ID NCT07358962

Knowledge-focused Sponsor: IRCCS Centro Neurolesi Bonino Pulejo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how mental health issues, like depression or anxiety, affect people with mild cognitive impairment (MCI). Researchers will study 118 adults aged 50-72 to see how these issues impact their awareness of memory problems, social life, and work. The goal is to better understand these connections to help design more personalized care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

50 to 72 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

agnosia Cognitive Dysfunction Social Adjustment

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild cognitive impairment (MCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Irccs Centro Neurolesi Bonino Pulejo

    Messina, Me, 98124, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.